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Farmas USA

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Farmas USA
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#55459

Re: Farmas USA

El viernes apareció un artículo bearish sobre CTIX en SA...

http://seekingalpha.com/article/2794245-cellceutix-overvalued-by-90minus-99-percent

Hoy acabo de recibir un mail del CEO, con el siguiente redactado:

My fellow Cellceutix shareholders,

Shareholders have alerted me that it seems professional short funds are at it again. For those who are unfamiliar with stock shorting, it is the hope by these shorters to have the share price of Cellceutix stock decline so that they can profit.* The last time this happened a couple of years ago, we saw biased articles and social media postings disparaging Cellceutix, commentary which lacked any real depth in research and, quite honestly, just made little sense to us. Most concerning, we saw manipulative premarket stock action showing trades happening at significantly lower prices than the previous day’s close (unusual manipulative trades meant to scare people), so we wouldn’t be particularly surprised to see similar happenings this time around. Whether shorters sell shares among themselves or otherwise, I just don’t know how they accomplish this. It bothers me personally to wonder if these well-planned tactics frightened any stakeholders into exiting their position, as the price of Cellceutix stock eventually appreciated over 200-300% subsequent to the malicious postings as our fundamentals served as the armor for us to easily weather the storm. Ultimately, we are proud of the fact that we have grown into a high profile company built upon clinical data and the strength of our pipeline, but with that, we are cognizant that can put us in the crosshairs of shorters. The words of a select few with clear ulterior motives do not even remotely dissuade us from our goals of striving to significantly grow corporate value. The best way to beat shorters is to continue to deliver fundamentally and that’s exactly what we intend to do.

Thank you for your ongoing support.

Leo Ehrlich
Chief Executive Officer, Cellceutix Corp.

#55460

Re: Farmas USA

Amarin to Present at the 33rd Annual J.P. Morgan Healthcare Conference

 

 

BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 01/05/15 -- Amarin Corporation plc (NASDAQ: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that John F. Thero, Amarin's President and Chief Executive Officer, is scheduled to present a general company update at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 15, at11:00 a.m. PT.

#55461

Re: Farmas USA

Al mismo tiempo, han publicado esa new....

BEVERLY, MA--(Marketwired - Jan 5, 2015) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to release additional statistics from the Company's recent, successfully completed Phase 2b trial of Brilacidin, Cellceutix's lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

On October 23rd 2014, Cellceutix announced positive top-line results for the randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of ABSSSI. The FDA-defined primary endpoint of at least 20% reduction in area of the ABSSSI lesion, relative to baseline, was achieved in all study populations at 48-72 hours, for each of the three Brilacidin dosing regimens and the active comparator, daptomycin.

In treated patients assessed at 48-72 hours, 47/51 (92.2%), 46/48 (95.8%), 51/52 (98.1%), and 45/48 (93.8%) achieved clinical success in the Brilacidin 0.6 mg/kg single-dose group, Brilacidin 0.8 mg/kg single-dose group, Brilacidin 1.2 mg/kg 3-day group, and daptomycin 7-day group, respectively.

The corresponding 95% confidence intervals around the clinical success rates were 85-100%, 90-100%, 94-100%, and 87-100%, respectively. It is important to note that this Phase 2b study was not powered for statistical comparisons. Nevertheless, because the 95% confidence intervals overlap, these clinical success rates are considered similar. Regulators prefer the use of 95% confidence intervals, rather than p-values, when comparing efficacy rates in clinical trials, as they can provide more information than p-values. A much larger study -- such as the kind done in phase 3 -- would have the power to make statistical comparisons.

On December 22nd 2014, Cellceutix also reported positive results in the Microbiological Intent-to-Treat (MITT) population. This is an important population that includes patients with baseline cultures positive for common ABSSSI pathogens, such as Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA). In this population, Clinical Success rates at 48-72 hours were again very high (above 90% across all treatment groups) and again very similar (with overlapping 95% confidence intervals).

"These results are outstanding across all dosing regimens," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "The Phase 2 data showing a one-time dose of Brilacidin achieving statistically comparable results to a seven-day dosing regimen for the current gold standard treatment for ABSSSI is fantastic and reason for great optimism going forward."

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Additional updates on Brilacidin and other drugs in the Cellceutix pipeline will be given at the Biotech Showcase 2015 conference being held at Parc 55 Wyndham San Francisco (Union Square) in San Francisco, CA on January 12-14, 2015. Cellceutix will be presenting at the conference on Monday, January 12 at 2:00 PM PT in Room Powell.

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#55462

Re: Farmas USA

Empezamos con AGEN ARRY CTIX CYTR HALO OIL SBFM THLD

En observación para posbile cambio, BTX ETRM GERN NVAX OGXI OREX

#55463

Re: Farmas USA

STXS

$STXS Stereotaxis receives FDA clearance of Vdrive with V-CAS system -

A ver si con esto me puedo salir sin palmar... que la llevo desde principios de 2014 en rojo intenso.

#55464

Re: Farmas USA

Sobre las aprobaciones de la FDA de un artículo de SA: aumento importante, especialmente por las enfermedades raras y los tratamientos del cáncer e incipiente presión de las aseguradoras para rebajar costes.

Esto enlazaría con el comentario del Bastardo y el artículo de Erdys sobre el reparto del mercado de la hepatitis y deja todo el espectro de fámacos secundones y más baratos para observar con detenimiento.

FDA drug approvals rise sharply

The number of drugs the FDA authorized this year rose to 41 from 27 in 2013, driven by expensive new treatments for cancer and rare diseases.

The 2014 figure is second only to the all-time high of 53 approvals reached in 1996.

Nearly 40% of new drugs approved in the U.S. last year were for rare diseases, which have continued to command premium prices. The high costs have led to tensions with insurers, which are starting to push back against the sky-high cost of the therapies.

«Después de nada, o después de todo/ supe que todo no era más que nada.»