Farmas USA

113563 respuestas
  1. Pathwin

    Re: Farmas USA

    Jodo!!!! Ahora que he podido abrir la bolsa y me encuentro con esto. Vaya putada y todo por una noticia de la CNN.
    Y ni un rebote en apertura, solo hacia abajo. Pfff no me gusta nada. Tenia un segundo paquete para invertir aqui y no se si pronediar o amputar al menos una parte.
    Hay posibilidades de que la FDA pueda retirar Nuplazid?
    Hay comunicado por parte de la compañia?

  2. Investing_saints
    en respuesta a Pathwin

    Re: Farmas USA

    Ver mensaje de Pathwin


    Sí que hay informe de la compañía, lo hemos puesto unos mensajes antes. Aparte de alguien en corto, la cnn le ha puesto la diana por las subidas de precio consecutivas.

    El riesgo que hay es que las ventas se resientan y que el aumento de pacientes sea aún más lento. Además de que haya algo más que no se sepa de efectos adversos, aunque a mí no me parece lo más probable.

    Si uno se lee detenidamente el informe origen del artículo, se ve que los datos no son de unos estudios sino de diversas fuentes y reportes, mucho menos riguroso, con muchos pacientes tomando la medicación junto con otras; en la fase 3 precisamente la fda puso black box por un ligero aumento de muertes en la rama de Nuplazid.

    No es nada que no se supiera, pero el mercado está en modo pánico y puede afectar al futuro según lo que la fda haga al respecto de los estudios en marcha. Ojo al gráfico, observad que no hay apenas reportes de médicos en comparación con el resto...


    Edito para añadir otro gráfico con % muertes para indicación similar y fármacos:


  3. Investing_saints
    en respuesta a Investing_saints

    Re: Farmas USA

    Ver mensaje de Investing_saints


    Mensajes en IV de biotech2k:

    Clearly, someone is out to get ACAD and Nuplazid. I don't think any of this is true, but I don't ignore things like this. I canceled all my bids for ACAD until I see this thing turn around. I am not going to throw more money into a company that is collapsing in price. I am in crisis management in ACAD and looking to just limit the pain it can do to my overall portfolio. Its already a sizable part of my portfolio at 7% position. This goes into the INCY camp. Something is clearly wrong that it is going so low in price. I can not ignore that. If I am right about ACAD, the stock will come back an go higher. I would rather make less money at this point then to throw good money after bad.


    This isn't the first time in the past 2 years that I have heard these bear raid stories about Nuplazid. They say, "it doesn't work" or "it toxic". None of which are true. Disproving the critics is always a tough road. I know SRPT went through the same thing for years. Now it is ACAD. I don't believe any of its true. That data doesn't support it. These patients are very old and frail. They are going to die. None of them have been linked to Nuplazid. This is just fear mongering for profit.


    I am not a CNS expert. There was a time when ACAD was up at $38 I thought about exiting CNS since I don't know the science that good. Its hard to have convictions in something you don't know that well. I am wishing today I had done that. If I do opt to exit CNS space, I would break about even on ACAD over the past 2 years. Hurts to watch it give up all my gains. I would still earn about 300% or more in SAGE over that same time. I am still thinking it over. Its not a decision I have to make today on such a bad day. I am sure ACAD will come back. This massive volume down day sure looks like capitulation to me. I might just ride it out for now.


    If you go back an look at the Phase 3 data, they only have a slightly higher level of deaths in the treatment group over the placebo group. The FDA opted to handle it with a Black Box warning. This sudden "to do" about the deaths is like the most captain obvious statement of the year. I think it states more about shareholder inability to do proper due diligence then anything. We already know about the elevated risk of death in elderly patients. Its right on the label. The issue with the early trials not working were about being poorly designed by the old management. Once they designed a proper trail for PDP, they did get very good results. None of this isn't information shareholders hasn't heard a dozen times since Nuplazid went commercial.

     Increased risk of death in elderly patients with dementia-related psychosis. Medicines like NUPLAZID can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.


    That is my I say, "Manage the risks and the winner take care of themselves." Right now ACAD certainly has risk. I can't say with 100% certainty that this whole article is rubbish. I know the trial data. It did have higher deaths. It wasn't enough to stop the FDA. They had data in phase 2 for ADP which had no elevated deaths.

     In the -019 Study, pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies. Based on a preliminary analysis of safety data, the most common adverse events reported were falls, urinary tract infection and agitation. The mortality rate was the same in the pimavanserin and placebo treatment groups. The mean age of patients in the study was 86 years.

    The overall data suggest that Nuplazid isn't any worse then placebo by much in a highly frail elderly patient population. The FDA gave Nuplazid breakthrough therapy after seeing the -019 data in ADP. They would not do that if they had any concerns about deaths. It is also not any worse then the rest of anitpsychotics they use for this indication off label. 

     The warning was prompted by a review of 17 placebo-controlled studies with 5,106 elderly patients on antipsychotics over a period of about 10 weeks. Study results showed that elderly patients who took Risperdal had a risk of death that was 1.7 times higher than those who took placebo. The specific causes of death varied from patient to patient but were primarily related to cardiovascular causes such as heart failure or heart attack and infections such as pneumonia.


    Perdón por el flooding pero creo que hay bastante gente dentro y mejor si tiene toda la información que se pueda para tomar la decisión que se estime oportuna. Es una farma complicada en una indicación complicada, ya sabéis lo que significa...

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