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Farmas USA

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Farmas USA
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Farmas USA
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#88826

Re: Farmas USA

Es lo que tiene el gambling, que engancha (es medio broma, no se me enfaden).

IONS
Un artículo que salvo lo del BO por parte de GILD que no lo veo, explica bastante bien algunos aspectos de la situación actual:
http://seekingalpha.com/article/3978127-trouble-strikes-ionis-will-get-bought-gilead

En los comentarios dicen que la reducción de plaquetas fue debida a usar una dosis mayor de la empleada hasta ahora y que además sería algo controlable. El que sepa analizarlo bien si investiga y descubre que efectivamente el mercado sobrereaccionó se puede llevar buenas ganancias. Yo como no lo veo claro no me meto. Además, los cortos se van a cebar a poco que el IBB flojee de nuevo (y aunque no).

Por cierto, antes habéis hablado de ACHN (creo), el autor del artículo compró hace poco en 8 medios y es optimista con su evolución...

Edito para meter más info de IONS, comentarios sacados de investorshub:

Esto fue casi a finales de abril, unas semanas después de parar el trial de IONS:

IONS ALNY - in the recent ALNY cc on their TTR PN OLE they speculated on the reason for the hold on the TTR-Rx cardiomyopathy trial:

Quote: "Importantly, we observed no clinically significant effects on platelet levels, which we understand to have been reported in the GSK/Ionis prorgan and may have been a factor in the recently announced clinical hold."

Amusing to, potentially, first hear about the reason for a hold from the competitor, and not the companies themselves.

--

Y hoy...

IONS’ partner, GSK declines to run phase-3 trial for IONIS-TTRRx:

http://finance.yahoo.com/news/ionis-pharmaceuticals-provides-ionis-ttr-113000191.html

--

Quote: Reading between the lines it would seems that a patient died and I'd venture platelet issues go beyond the two programs by the deliberate wording of "at these levels" remarks.
-
Agree it seems likely that someone died - since he refused to give a direct answer. Further I would speculate it was with APOC3 FCS trial just because his tone when asked a specific question about the APOC3 events was very down. Also, if someone had died in the older TTR trial we probably would have heard about it already.

The other interesting things on the CC were:

a) His odd denial that there was a class effect despite being seen in multiple drugs now. Clearly this is a classic Stan semantics issue.

b) He points out that there have so far been no events in US sites and that there have been no events in the long trials at this dose in the various ph2s and OLEs (and I'd acknowledge this is odd given that this is not a small number of patients on the drugs for the 4 months it takes to see the problem).

c) The timeline (it shows up at about 4 months) is odd (e.g. Drisapersen also has a thrombo issue - but it shows up later)

d) He was asked explicitly about whether he was certain these events have happened in the treatment arms and he said that they are still blinded, but he thinks it very unlikely they are in the placebo arm.

e) The items they are exploring for potential cause are higher dose, sequence related, disease interaction (the latter seems unlikely given the appearance of an event in APOC3 trial - but I am sure they haven't reset their sights yet with the new APOC3 data).
--

IONS - thrombocytopenia further thoughts:

a) There is some chance this is a broad class effect and would spread to other companies as their ph3s get fully enrolled and time on trial increases (e.g. similar sudden onset thrombo in Dris (a different technology) and general, but less extreme, thrombo in others).

b) If, in fact, a patient died I don't see how Ionis avoids a broad stop-dosing hold for all systemic administration trials. If this lasts any length of time it damages the ph3s even if(!!) a solution is found.

c) The neurological trials (large pipeline of agreements with BIIB) may be safe. But I'd want to see the general (ITT average) platelet levels plus SAE thrombo data.

d) The R&D Day in July is likely to get cancelled - too much of their pipeline might have just gone 'poof'.

e) I'd be surprised if at least one of their partners for systemic usage doesn't drop them in the next year.

Note: I would say that I think that if anyone figures out what is causing this it is likely to be Ionis. They have data which others don't and are good at the science (just very very ostrich-like when it comes to adverse events).

http://investorshub.advfn.com/boards/replies.aspx?msg=122919464

#88827

Re: Farmas USA

Si cambian la dosis a 200, implica repetir el ensayo clínico entero con la nueva dosis. No me puedo imaginar que hayan sido tan negligentes de no haber diseñado bien el EC a dosis adecuada. Tendrán sus morivos para haberlo hecho a 300. El programa de Glaxo no es el único que provoca trombocytopenia. ALNY medica a la vez con esteroides y si IONS decide hacerlo así tb, tendrán que re diseñar el estudio de nuevo. De acuerdo en que ellos (IONS) son los que saben más que nadie que puede haber pasado, a ver si pueden ser capaces de solucionarlo pero después de las ultimas news, A corto plazo ALNY va a ser el líder en amiloidosis y puede que a medio/largo plazo, surjan nuevos competidores que lideren el sector con nuevas tecnologías para esta enfermedad, como probablemente sea NTLA (amiloidosis va a ver su primer Target)

#88828

Re: Farmas USA

Entonces que, pasamos el IBB de los $300 para ASCO?

#88830

Re: Farmas USA

Se esta poniendo esto muy calentito, todo muy apretado, va siendo hora ya de retomar sendas alcistas, ¿no creéis? Y al dólar también le toca decidirse pronto.

Paciencia.
Es difícil tenerla, pero trae muy buenos resultados.....

#88832

Re: Farmas USA

Yo no veo tan complicado más de un 4,30% el martes, no es una gran subida para NVAX, con que todo acompañe un poco, estaríamos tanteando esa resistencia de la MM150 y llegando a la parte alta del canal.
Con una new, se podría pulverizar.

NVAX

Paciencia.
Es difícil tenerla, pero trae muy buenos resultados.....

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