Farmas USA

bonito after el de ACHN +5% - 8,38

edito: que con 1.700 shares han vuelto a dejar en su sitio 7,97
:(

CLSN

Como dije la peseraba en 0,95 y aqui está. Vere esta semana como se mueve para decidir.

Buenas noches!

Llevo un par de semanas algo ausente por temas familiares y enfermedades (nada serio) pero leo cada post del foro

Con los meneos de estos días he optado por volver a ARNA a ver si es verdad que el soporte de 8 se porta bien y esa sangre azul que indica el Koncorde nos sirve para algo bueno.

Y como soy cabezón también he entrado de nuevo -aunque no muy fuerte- en ZGNX que tiene FDA este viernes. Sigo pensando que aún con restricciones la aprobarán y en caso de no ser así ya tiene una buena parte descontada y aún con todo la empresa cuenta con otros productos interesantes.

Aquí un informe reciente de Wells Fargo. Es un buen resumen de cómo esta la situación con esta empresa.

Equity Research Zogenix, Inc.
Maintain Outperform

ZGNX: AdComm Said No To Zohydro ER, But FDA May Not Listen

• Summary: FDA AdComm voted against approval of Zohydro ER, but FDA decision (PDUFA: 3/1/2013) could be different, in our view. The vote was more reflective of dissatisfaction of the drug class and its current REMS, and we are unsure if FDA will single out hydrocodone by imposing more stringent requirements. We continue to believe an approval is a probable outcome, but cannot rule out a modest (several months) delay. We would buy on weakness resulting from the "negative" vote.

• AdComm voted 2-11 against approval of Zohydro ER. On the surface, the panel appeared overwhelmingly negative, but we believe the direction of the vote reflects dissatisfaction of the entire class (extended-release C-II opioids) rather than with Zohydro ER itself. The panel was uncertain about the robustness of the class-wide REMS program. Specific to Zohydro ER, the panel was concerned about the lack of tamper-resistance characteristics in the formulation under review. Zohydro ER is an extended release hydrocodone for the management of moderate to severe chronic pain. The PDUFA date is 3/1/2013.

• FDA has a dilemma. The main complication for FDA is that it has to view Zohydro ER in the context of the entire class of extended release C-II opioids, and at several instances encouraged the panel to highlight any Zohydro ER-specific differences over the class. So should FDA single out hydrocodone by requiring longer-term studies to #$%$ safety/efficacy and a more stringent REMS program? Also, will FDA require tamper-resistance to be incorporated into Zohydro ER when there is no labeling for tamper-resistance? And what happens to the other non-tamper-resistant C-II opioids that are on the market now?

• Approval is still a probable outcome, in our view. Our reasoning is based on FDA's acknowledgement that Zohydro ER is effective and safe when used as intended. At the same time we do not believe FDA will require a more stringent REMS program for Zohydro ER, other than incorporating the voluntary measures proposed by ZGNX. Of course, we cannot predict FDA action with certainty, and FDA could extend the review period to buy itself more time.

• The major risk to our position is requirement of tamper-resistance in the Zohydro formulation. By ZGNX's admission, its tamper-resistance formulation is several years away, so such a requirement would result in a multiyear delay. However, such requirement would run counter to the fact that FDA has not allowed tamper-resistant claims in the label of approved opioids.

Valuation Range: $3.50 to $4.00

We derive our valuation range by applying a P/E multiple of 13.0-14.0x our 2015E EPS of $0.35, discounted back for two years at 14.8% per year. Risks to the stock trading to our valuation range include regulatory setback for Zohydro ER and deceleration in Sumavel DosePro Rx growth.

Investment Thesis:

We like the value proposition of Sumavel DosePro and Zohydro ER. We believe management's ability to hit financial guidance, grow Sumavel DosePro, and advance Zohydro ER are potential catalysts.

ACHN - 13G SEC FILING

os acordais de QVT Financial? los que entraron en Agosto a 6,5x.
segun esto han seguido acumulando, para el 31 diciembre 2012 tenian el 8,87%
y a fecha de 22 Feb 2013 , han acumulado hasta el 11,59%.

http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001193125%2D13%2D077264%2Etxt&FilePath=%5C2013%5C02%5C26%5C&CoName=ACHILLION+PHARMACEUTICALS+INC&FormType=SC+13G%2FA&RcvdDate=2%2F26%2F2013&pdf=

Alto riesgo, una votación 11-2 en el Adcom no da muchas esperanzas. El rechazo está descontado pero un bajoncito especulativo de un -10 o -15 es muy probable. Yo esperaria al día de la cita y entraría en el bajón. Espero equivocarme. Suerte!

Si, sin duda el riesgo es muy alto de ahí que la cantidad a arriesgar sea pequeña.

Además si de aquí al viernes le diera por cerrar cortos o tuviera un incremento hacía el 1,40 o similar la soltaría sin pensarlo.

Salu2!

Hartito estoy ya de todos los articulos bearish con AMRN. que salen ... en verano todo era de color de rosa, un blockbuster.
Ahora todo negro ...

http://seekingalpha.com/article/1228071-amarin-the-more-you-know-the-fishier-it-gets?source=email_rt_article_readmore

y justo al dia siguiente de solicitar el NDA ... curioso