España
No se, me sorprendería un poco que se diera un BO ya. Pero nunca se sabe. ME pasó hace relativamente poco con NPSP (comprada x Shire) así que nunca se sabe. De todas formas mi entrada fue pensando en el NDA, y bajo precio del stock.
MTSL - Bioinvest 825
http://www.bioinvest.com/wp-content/uploads/2016/04/MTSL-Issue-825.pdf
UPDATES: BMRN, IONS, MDCO, XON
Como siempre, lectura recomendada, subo la parte general.
SENTIMENT — M&A Speculation Is Alive Via PFE/AGN Split, Helping The Grind Up —
The start of the second quarter has begun to erase some of the pain of the biotech bear market, but only some. The first three-week gain in the NBI index since October led to a technical, short-term overbought condition, and a bit of profit-taking took place before finding a new higher floor. This level was put in place when it was confirmed that MDVN rebuffed a real bid from SNY. Although not a move to a bullish scenario, the sentiment undoubtedly feels healthier than the last quarter.
Fundamentally, there have been two important positive regulatory events – the FDA AdCom recommendations for MTSL’s ACAD and now ICPT – that should lead to upcoming approvals for a couple of new blockbuster drugs. The respective stocks have done well, although ICPT has sold off somewhat since then despite receiving a unanimous recommendation. A bear would say that a recommendation is not yet an approval, so we still need to have official confirmation. In the meantime, that kind of stock action – run-up on the briefing documents and selling on the news – is one reason we say that only little of the pain from the recent past has been erased. In a stock picker’s market, the action is predominantly in the large cap names and traders playing select stocks that have events on the docket (e.g., FDA panels or approvals, upcoming data releases, scientific meetings). Fund flows continue to be negative (albeit less so than the past) and, after a horrific Q1:16 performance, additional redemptions/liquidation may also be occurring as investors receive their frustrating, quarterly biotech stock statements. Such action depicts the grind up.
Ironically, while we have been waiting for the meaningful takeover in biotech, the key catalyst that spurred a major rally since the last Issue was actually the break-up of the Pfizer-Allergan merger. The Big Boys are no doubt out shopping for pipelines, and even more so after the merger-hungry tax avoiders split up. Additional M&A related press releases (e.g., RLYP) further fueled the speculative fire and the BTK had its best single day since 2009 on April 6 . After MDVN hired some bankers in reaction to inquiries by possible acquirers, we suggested that the inevitable takeovers were approaching. But as usual in this biotech market, the pullback right afterwards (see NBIDaily chart) suggests that the upward move was mostly led by short squeezes and a technical index trade, not by new buyers coming into the group. The feeling out there is one of less negativity (2 steps forward 1 step back), which overall one can say is positive. The NBI chart broke cleanly above the 50-day MA since the last Issue, and the 50-week MA, also looks healthier. Stock selection remains paramount and as such the AACR (e.g., cancer stocks) takes place this weekend, and the participating stocks (e.g., MTSL’s INCYand FPRX) have done relatively well since the abstracts came out. From what we can tell, first quarter earnings reports at the Big Bios will meet and in some cases exceed consensus. That can only help improve sentiment. With both new drug approvals and sizable buyouts nearing, that gets us a bit closer to crossing off our checklist.
M&A – RLYP Up On Buyout Possibility, Following MDVN
While Medivation is working with bankers to thwart off presumably low-ball bids and a deal may or may not occur, Relypsa said it is exploring an actual sale following the receipt of offers from a “number of potential buyers.” RLYP’s action has more credence than the MDVN one, hence the former’s >50% gain (vs. the latter’s ~20% rise). GILD also made a decent sized deal, buying closely-held Nimbus’ NASH-drug development program for $400 million in cash up front and possibly another $800 million on the back end. All three announcements triggered a solid bounce in the biotech indices and in typically discussed takeover targets (e.g., MTSL’s ACAD, ALKS, BMRN, FPRX, INCY, IONS and MDCO were included in the previous week’s best performers).
While the GILD deal (and even a subsequent larger Alzheimer’s disease deal for AGN) are evidence of continuous business development activity despite the weakness in share prices, there has still been no large sized acquisitions. By that we mean a deal for a public company for at least $5 billion, if not more. As a reminder, the Big Bios/Pharmas with their giant bank accounts (e.g., MRK, GILD, AMGN, LLY, PFE, etc.) have mentioned going shopping to the tune of $10 million or so. A MDVN deal would fit the bill and the stock is holding up well (market cap now over $8 billion). However, it appears likely that the spread between the bids and asks are still wide apart. The increase in prices of takeovers could force some hands and, we believe, as we get closer to the Presidential election, some of the political pressure will die down and the M&A reticence will lighten.
REGULATORY – ICPT’s OCA Gains AdCom Recommendation, But Clovis Does Not; ABBV/Genentech Breakthrough Makes It
Coming on the heels of the ACAD Nuplazid win, ICPT’s unanimous OCA recommendation gave the sector a strong two-for-two batting average after a rough FDA/regulatory period. Since the negative CLVS briefing documents and subsequent panel occurred after ICPT, the market’s ‘what have you done for me lately’ mentality became a negative catalyst for the bios and the trade was down. On the plus side, the sector has resumed a short-term bounce after the fact and appears to be looking at the good FDA early approval of ABBV’s venetoclax. Roche/Genentech and AbbVie were granted accelerated approval to market their ‘breakthrough’ cancer drug venetoclax as a new treatment for patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion. The compound, formerly ABT-199, was a former potential competitor to Pharmacyclic’s Imbruvica – until ABBV succumbed and acquired the now market leader. Nonetheless, ABBV now has a strong platform for NHL with two oral drugs on the market. When a company does the right thing – performs solid, well-designed pivotal trials with true statistically successful endpoints – the accommodative FDA does its job on time and usually okays the new drug. The bull market of the past few years, unfortunately, has led to some short cuts by previously high-flying companies that resulted in a logical regulatory rejection. That hurts group sentiment, but the upcoming approvals of ACAD and ICPT are no doubt helping to improve the current very low investor expectations.
EVENTS – Investor Conferences, Q1 Earnings Due & ASCO Abstracts
This past week, boutique brokerage firm Needham held a healthcare conference, giving investors a recent update of fundamentals of mostly small cap stocks. While attendance is solid and there is strong attention given to many companies, most investors seem to be waiting on the sidelines and, after the bloodbath since last August, are willing to buy stocks after key information is released. Such was the case with ACAD and ICPT – whose stocks rose only after the release of the favorable FDA briefing documents. Also, stocks with positive AACR abstracts have also performed well – again rising only after the release of the abstract book. This kind of behavior exemplifies the current “risk-off” mentality of most biotech investors, as core holdings are made up of bigger cap, less risky stocks such as AMGN, BIIB, CELG and GILD. The actual AACR meeting – a cancer symposium focused mostly on early but next-generation compounds and technologies – begins this weekend in New Orleans ( http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63&DetailItemID=224#.Vw10WmO4ER4 ). MTSL’s FPRX’s FPA144 – a very strong performer of late – will be featured during a special session at AACR. The American Academy of Neurology meeting also starts this weekend, where MTSL’s IONS will have several presentations. And the widely watched ASCO abstracts will be released next week 4/20. In this environment and at current valuations, the risk-reward of most biotech stocks is skewed in favor of being long (e.g., GWPH, CPXX). Add in a quick look at the changes in the latest short interest below, hence the massive short squeeze of April 6 .
Listado de Catalizadores próximos y Short Interest
As the table above shows, the majority of MTSL stocks had increases in their short interest positions as the first quarter came to an end. Even stocks with strong favorable events such as ACAD showed a meaningful rise (+10%) in their already all-time high SI after the panel. Also, the MDVN speculation did little to change the already high short positions – a sign that we believe shows two things. First, that until the last SIreading, shorts did not believe that biotech stocks are ready to mount a sustainable comeback. And next, that a single takeover like Medivation may not be enough to reverse the negative fund flows. As the table also shows, many of our Portfolio names have important catalysts coming inQ2. Last but certainly not least, first quarter earnings/fundamental updates of the Big Bios are looking to provide further evidence of the earnings and innovative power of biotech.
As we mentioned last Issue, the start of the second quarter not only puts the first quarter behind us, but it also brings us closer to a greater number of clinical, regulatory, scientific and takeover events. The multiple events above (e.g., MDVN, ACAD, ICPT, RLYP, GILD, etc.) taken together, and positive earnings reports, must have the shorts thinking twice. And the Presidential election will no doubt come and go. In our view, the aforementioned scientific conferences, FDA approvals, potential mergers and acquisitions, and the release of ASCO abstracts combined have the potential to lead the group higher.
NOVAVAX
- NEEDHAM HEATHCARE CONFERENCE - TRANSCRIPTION
April 2016 -
CONFERENCE CALL PARTICIPANTS
Stan Erck
Scott Pettit
PRESENTATION
Unidentified Participant
Okay. Good morning everybody and welcome to the 15th annual Needham Healthcare Conference. Very happy to have presenting for us at this time Novavax and represent ting for the Company is their President and CEO, Stan Erck.
Stan Erck
All right. Thank you and good morning, everybody. Welcome to the Novavax presentation. I will spend the next couple of minutes introducing the Company and the opportunity and I will turn it over to Greg Glenn to is our President of Novavax R&D and head of all of the technical and clinical development for the Company and he'll give you the meat of the presentation which is the clinical status of our programs.
We have -- as you all probably know we are a vaccine company. All of our products are based off a single platform of developing nano particle-based vaccines which can be used across a broad range of pathogens. We have now late stage products. As you'll hear we've entered two Phase III clinical trials. We've over the years developed great partners for both the relationship with BARDA, who has funded the development of our platform for influenza. Their primary interest is for pandemic influenza and ours is to develop a seasonal influenza vaccine based upon the nano particle technology and with the Bill and Melinda Gates foundation to recently joined us in funding a program for maternal immunization which Greg will tell you about we are developing products for large markets and plan on taking our first product into the market on our own. So the pipeline as you'll see from the slide is robust. We have last year in 2015 we unblinded five clinical trials in the time frame for roughly June through September.
All of those trials gave us data that had a smooth the products forward through late stage clinical trials. Two of them ended with end of Phase II meetings with the FDA which is the meeting that you have in advance of a Phase III initiation and both of those meetings were successful. In November we started two Phase III clinical trials. In the fourth quarter of last year I think that's possible -- it's unprecedented in biotech history for a company with its first two products to go into Phase III clinical trials at the same time period. The first trial was in older adults where we vaccinated 11,850 people over a five week period in November and early December and then we began our first trials in pregnant women in December in the US and have followed that up by developing a global program and vaccinating pregnant women in South Africa.
We have a pediatric program in RSV which represents a third of the three RSV products. Influenza trials in both the Quadra valent seasonal vaccine and in pandemic influenza. And then new opportunities -- our platform allows us to address emerging viruses such as Ebola, a seven and nine and the pandemic and others very quickly. And the last program that you see on this slide is our combination respiratory vaccine where we combine both the flu vaccine and the RSV vaccine both of which are seasonal diseases overlapping each other. Flu and RSV season in the Northern Hemisphere occurs in roughly December through April and atypical time to get vaccinated is in the fall in advance of the flu season. So our goal is to have one vaccine ultimately which addresses both RSV and influenza.
So our platform is a new paradigm. We have -- I'll let Greg explained this further but we have a technology that allows us to make antigens uniquely that expose surface areas that stimulate very robust immune responses to pathogens that aren't stimulated similarly by other traditional vaccines.
The Company strategy has been and continues to focus on large market opportunities. Our goal is to have the first RSV vaccine. This is a disease area that companies in the vaccine world have focused on for as long as 50 or 60 years. We made a breakthrough for five years ago in a Phase I trial and we've been following that up in Phase II and now in Phase III. So it's a competitive fields that we've left ahead of by at least a couple of years and we have developed the first vaccine to show efficacy in any population for the RSV market.
We will develop the RSV vaccine first in the elderly and bring it to market in the US and plan to partner it outside of the US with global vaccine companies. So it's a large market. The RSV market is a large market. We think it's the biggest unmet need for a vaccine that exists right now. It carries a huge disease burden approaching $100 billion in the large developed countries but it's a global problem as well. And we are developing the product particularly for pediatric -- to protect newborns by vaccinating pregnant women globally. So what we'll talked about is the three target markets. In older adults there are over 2.5 million annual infections in the US. Maternal immunizations -- 1.4 million infants contract RSV and as I mentioned before very large market her disease burden. And we'll develop both these vaccines in Phase III -- so over the next year or two. And with that let me introduce Greg Glenn who will talk about introducing the technology and the state of the clinical trials. And I will also entertain you with a video which shows our technology in a cartoon fashion. (video playing)
Scott Pettit
Okay. Well thank you very much for coming this morning and your interest in Novavax and RSV. As a grizzled vaccineologist I can tell you it's a very exciting time in my field in particular with RSV driving a lot of that excitement. If you were trying to change global public health you would invest in clean water for the world and vaccines. So these are technologies that are going to have a major impact based on the disease burden and the effectiveness of the vaccine.
So to that point you can see a US flag in the corner there. This is a comparison of the disease burden from two license vaccines in the same space and you can see the larger circle represents the number of infections and as you can imagine sort of the peer amid of severity of disease represented here by circles where you see hospitalizations and deaths. And the point of this is to illustrate the burden of RSV disease as we understand today in comparison with some vaccines that are licensed in terms of hospitalization and deaths RSV compares quite well with both influenza and pneumococcus where there are licensed vaccines. And particularly pneumococcus is of interest because the market size for the pneumococcal vaccine -- the new vaccine called Prevnar is very large and I think quite comparable in terms of its market.
This is -- now a relevant study for us as we are in a Phase III trial -- as Dan mentioned we just started this in November of this year and have just moved through an RSV season. Our trial single-season RSV trial where we immunized adults 60 and older and then they are doing active and passive surveillance through the season.
What this slide illustrates is the relative predictability of RSV disease. This is a 14 year study looking at the burden of disease. RSV in the UK and in primary care setting the upper graph and then with hospitalization and death below. And you can see in red RSV and in blue, flu. So a couple of points -- the attributable disease burden RSV is quite high and very comparable to seasonal flu in the study and then the consistency of which you see RSV attack rate which is really critical for trial conduct is illustrated as well. So RSV is what I would say is a predictable annual epidemic. So when you do your trial conduct in your operations that's extremely important. There is a well circumscribed season and a consistent attack rate for RSV and that's been the case this year for us during this really critical time of our Phase III trial.
So Stan mentioned that we've made in RSV-F protein. This is the fusion protein that acts like a syringe to inject the genetic material of the virus in the host cell and its structure and function is important. It actually has sites that are what we call highly conserved -- so RSV has been around a long time. It undergoes changes, like flu. So as a vaccine maker targeting the parts of the protein that are conserved and do not change from year to year it's really a big breakthrough so we can make one vaccine and use it again and again -- unlike flu, which requires chasing these strains that evolved over time. So site one, site for, and site to our sites that we will call conserved and they elicit what we call broadly neutralizing antibodies.
So you have immunity to those sites -- the strain changes are then not going to decrease the vaccine. What's been so particularly compelling for us going into a field where there has been 60 years of attempts to make an RSV vaccine is site two was defined by meta-meme in the past -- they made a monoclonal antibody to the site, called palivizumab. That monoclonal antibody binding to that site has been shown to be effective in preventing RSV in five randomized clinical trials. So the biology of this F protein-based approach has been proven -- well it's proven in our view. And we presumed that if we made a vaccine that could elicit this type of immunity then the vaccine should be protected. And I think we stand here today with now evidence that that hypothesis and paradigm is actually true and we've had Phase II data showing it's in fact protected.
So we can measure antibodies at site two. They are called palivizumab competing antibodies and I'll show you some data on that in just a second. So last year we did a fairly large Phase II trial in vaccines. You can often test the efficacy of the vaccine before you go to pivotal trial. And this trial was designed to describe the epidemiology of RSV in the context of the sort of trial we are doing in Phase III. So to describe the incidence or the attack rate of RSV and look at the immune responses and then to look at the vaccine effects in terms of estimating the efficacy. So we did that – it was a very I think instructive trial for us in Phase II and that allowed us to define the endpoints for the Phase III trial we are currently undergoing.
Here you see the immune response to the vaccine over time. This is a single dose given as an injection -- typically like the flu it would be an annual seasonal vaccine in our view. And you can see the blue line represents the anti-F IDG responses from (inaudible) from subjects who were not given the vaccine. And actually what you can see there is there is a fair amount of anti-F immunity amongst the general population and that's a result of the annual or semiannual -- sorry every other year infection that most adults have. So you all get RSV infections on a frequent basis. You develop very robust immunity but the enigma here has been that the community is not protected and but you can see here based on placebo that it's common to have quite robust anti-F immunity amongst the population. When we vaccinate you can see we have about a fivefold rise. These are again older adults -- so they are over 60 so they have relative immune senescence and yet our vaccine is giving quite a robust anti-F IDG response.
When you look at the palivizumab at site two that reflects the kind of immunity that was seen with the monoclonal antibody. Again, you can see quite robust responses and these would be at levels that we consider should be in the protected range if it mirrors these sort of efficacy seen with palivizumab. Again very robust responses. And what's interesting here is despite the fact people have had recurrent infections, the blue line actually is drawn
at the limit of protection which means that amongst the general population there's almost no antibody to this conserved site and we think that that's been an important explanation for the reasons that people have recurrent infections from year to year -- because they don't have this type of activity which we think is a critical feature needed for protection. So our vaccine displays the site induces immunity to it and in contrast to natural infection it should be therefore protected. And this is what we saw. This is a Kaplan-Meier curve. You can see time is on the X axis and the percent of subjects that did not have RSV over time developed -- first of all what we determined here which is consistent with what we saw in the literature is we had relatively -- we had a 5% overall rate of RSV infection which in the context the vaccine is a very high attack rate. And you can see the divergence of the vaccine population over time really persisting throughout the season. This is a highly significant effect of the vaccine – so decreasing the rate of RSV infections.
Now when you look at this in terms of what we might take into our endpoints you can see here now that we had a 40% reduction in RSV infection of any kind, which I think is a very high bar for vaccine. And then we looked at clusters of lower respiratory tract symptoms we saw that the vaccine of efficacy was around 64% and the more we clustered this in terms of lower respiratory tract infections the greater the vaccine effect. So how does this compare to the licensed vaccine Prevnar which has been commercially very successful from a public health standpoint – very successful vaccine. And you can see here in their Phase III trial they saw sort of the middle bar there is what their primary endpoint was to reduce vaccine strain related confirmed community acquired pneumonia. And they saw vaccine efficacy around 46%. So that's what their label claim states -- prevention of vaccine strain confirmed community acquired pneumonia and that efficacy is having a large impact on the public health of pneumococcus.
If you look at a more severe outcome which is the secondary endpoint of the trial -- invasive pneumococcal -- you can again see the vaccine efficacy increases as you go up in the severity of the disease. So very much reflecting our experience from any RSV to more severe signs and symptoms as you see vaccine efficacy declines. Now if you look again at the upper table these two findings now are what we have taken into our Phase III trials or endpoints. In this we made our primary endpoint reflecting this sort of outcomes you see here and in this we've made our secondary endpoint. So what are we doing? I know as a mentioned in November we enrolled 12,000 subjects. These are people that are over 60. They have -- they are fundamentally healthy. They have cardiopulmonary disease but they are not in the hospital. And our goal here -- our primary endpoint is to prevent moderate to severe RSV associated lower respiratory tract infections as defined by these multiple lower respiratory tract systems. The FDA did us a great favor by giving the moniker a moderate to severe RSV infection. So we are looking to prevent moderate to severe RSV infection. It's all been -- they were immunized in the November/December time frame. We are going through a single season. This is 16 sites across the US.
So what does that leave us? We are about done. Surveillance will end in May. We expect to announce the data in the quarter three time frame. That will allow us to then file a BLA and you can see the March to buy structure through FDA approval and then launch. So we are going to also turned quickly to the incense. So here we are trying to protect infants through immunizing from other. This is a natural mechanism by which infants -- when they are born they have acquired the complete repertoire of immune responses -- antibody responses that the mother has acquired through life; so they are protected for the first few months of life. The enigma here again as a mentioned even though they do have a very high level of RSV antibodies these are not highly effective in protecting infants so the peak disease in infants is in the first few months of life when they are in fact armed with the antibodies from the mother.
So what we are doing is immunizing from others. They have 100% of the mothers antibodies. This is a mechanism where the antibodies are transferred actually from the mother to the infants so it's a very elegant mechanism used by licensed vaccine for flu and pertussis to prevent those diseases in the infants themselves. We of course are looking to see the transfer of these palivizumab like antibodies in others that are broadly neutralizing. So we did a Phase II trial. We reported results last fall. Really it was very much about safety in infants and mothers. And in looking at the immune responses in the infants and mothers and looking for antibody transfer to the infants as they are our primary target what you can see here is the placental antibody transfer we have a number of immune measures including the response to the vaccine and the F protein. The palivizumab like antibodies -- and these are called neutralizing antibodies. What we found here is that you can see quite robust transfer. In fact there's relative concentration of antibody from the infant to the mother -- or sorry, from the mother to the infants and so they end up with roughly 20% more antibodies. This just is a somewhat complicated slide in that we found which is consistent with the literature that if there is enough time for the antibodies to (inaudible) -- those immunized mothers who delivered 30 days after immunization had more robust antibody transfer than those who were essentially immunized and delivered within a few weeks of the immunization.
These are robust responses. They should be protected and we are quite optimistic that that will be the case in infants. There is one other feature here that we have on our website that is kind of complicated, but these are these broadly neutralizing antibody sites. This is a palivizumab site. There are others that were defined long ago. Met immune simply selected one to commercialize. These others are expected to have the same activity. And it's the same story if you look in the general population -- these are the main mean titers. They really float around the limit of quantitation -- that is they are very very low. They seem to be hidden. Our vaccine is soliciting very robust antibody responses and those are being transferred to the infant. So we have many reasons to expect the vaccine should be efficacious based on the science and the historical experience with these antibodies. So the Phase II trial we had very well tolerated vaccine. It's highly purified -- you expect that. We had robust antibody transferred to the infants with around 120% antibody levels showing up in the infants. And we expect that to have a half-life of around 41 days and we expect to have very robust protection for at least a minimum of 90 days which is reflected in our endpoints. So here we started a Phase III trial. It's a global trial so RSV is a global disease -- it's predictable epidemic in infants and seniors and we've gone -we've taken advantage of factors in northern and southern hemisphere that's very well-defined. And here we are looking to prevent lower-respiratory tract infection as measured by hypoxemia which is a pulse oximeter measure of the infant. So when they have disease they stop oxygenating well and we'll look for that for the first 90 days.
This is PC are positive so this is active and passive surveillance is going on. We'll do a secondary endpoint which is a more severe hypoxia and also looking for the vaccine effect out to six months. This is a large trial -- global trial. It's done in a group sequential manner which allows us to adjust the trial size base on the vaccine effect that will be evaluated in a positive fashion by independent DSMB. And we mentioned earlier this is a major priority at the foundation. They've thrown in $90 million to support this Phase III trial. This is really historic. We have a lot of excitement in our world -- our little vaccine world based on this trial. So these are reasons that we've had a lot of confidence moving forward. First of all, we did a lot of work at a preclinical model which was predictive for palivizumab efficacy in the field so we had many things to look at especially the antibody levels and their qualitative effect. So we do pretty early on that are vaccine should be protective. We then saw as we look at our different dosing regimens and in vaccines you have to in the Phase I and Phase II setting you determine your dose and your dose schedule and we -- as a secondary we also look for -- these people went through an RSV season. We saw repeatedly that we were reducing infection in healthy women of childbearing age.
Again I would say a very high bar for vaccine biology -- biologic effect. So that gave us confidence. I just reviewed for you that we were able to show in a prespecified manner that we could prevent symptomatic RSV infection in older adults and this efficacy was greater against more severe endpoints. Again very consistent with the general findings from the field of vaccineologist. And then we think we are in very good shape with transferring those antibodies to infants in the maternal immunization setting. There has been -- this is not new. There's been a tremendous amount of activity because the disease burden and the market size is so great over many years. There's been very few trials that advance out of Phase I. This a lot of activity in Phase I still. We have -- you can see we are in Phase III and I think we are several years ahead of the competition. GSK has a maternal immunization program and met immune has an older adult vaccine program that are again in Phase II.
This just very briefly -- is influenza. We have shown nice data in the Phase II setting under our contract with BARDA to make both a quarter Valent seasonal vaccine and a pandemic vaccine which is what BARDA is primarily interested in being able to respond to a new novel strain of flu that might come through. We believe there is great commercial opportunity for combining the RSV and flu vaccines on our lifecycle management. We are expecting to get into a trial to show this. I think it would be very instructive even though it would be a potential Phase I trial. As we've learned so much about RSV in our Phase I trial we expect to do the same with our combination respiratory vaccine.
So here's our calendar -- Phase III pivotal trial. It's a big year for us. This will be a historic result in older adults. That data will be in the third quarter. We've also done a booster trial because this is an annual seasonal vaccine, so it's important to show its face and it has an immune response that's built so over one year of the immune response to our vaccine should be expected to wane. This is actually a very important trial and then we expect to initiate the trial in this combination respiratory vaccine. In summary we are the only RSV vaccine to demonstrate protection. We have two Phase III candidates. We have a first in market commercialization advantage global rights and this is a very good technology that has applications to many diseases. I think with that we will take questions. Thank you very much.
QUESTIONS AND ANSWERS
Unidentified Caller
(microphone inaccessible)
Stan Erck
We built then a lot of wiggle room. So this has been what I would say is a normal RSV season. What may help us is it has not been a normal flu season so if you look at the CDC website you can track what happened with influenza like illness during the first two months of our surveillance period there was almost no flu in the US. So I think that will help us. Just enriches the PC are positive rates. But otherwise it looks like a very what I would say normal RSV season. Again, you can track that at the CDC so that's a very important point. We've been as I mentioned at the beginning -- I think we've known this from history that RSV attack rates are extremely predictable and that it's critical for conduct in the trial. So we are able to I think justified taking this in a single-season US trial based on that history.
We built then -- we powered our trial for our primary endpoint over 90% so very robust power so that allows us to have wiggle room both in the estimate of vaccine efficacy and attack rate.
"Surveillance will end in May" , que a mi entender significa que en Mayo la fase 3 quedara unblinded y lista para iniciar el analisis de resultados.
NVAX
KITE
Creo que alguien la llevaba o seguía. Han parado la adición de pacientes en algunos trials por una revisión en las facilidades del NCI.
https://mobile.twitter.com/apppro1/status/721793658501140480/photo/1
Mañana a Magura le va hacer cortocircuito su sistema ...
-6% el crudo .... telita ....
Yo no tengo KITE pero si JUNO. Puede que esto beneficie a JUNO en el corto plazo y que esto se supiese y por eso JUNO esta subiendo con respecto a KITE estos días. Mi intención es soltar JUNO o por lo menos una parte, antes de ASCO, si pasa de los $50. (Mi entrada fue $34)
