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Alexza (ALXA) -34.4% premarket after it says its new drug application for Adasuve, a...

Alexza (ALXA) -34.4% premarket after it says its new drug application for Adasuve, a schizophrenic and bipolar disorder treatment, can't be approved by the FDA until a deficiency at a manufacturing facility for the application is resolved.
Comments (2)
  • lownav67
    , contributor
    Comments (7) | Send Message
     
    Without being privy to the actual letter, while this is just another of many setbacks/issues for this company, it suggests the FDA intends to approve. Otherwise, it seems logical to believe that simply would have rejected. Not logical to believe they would be requiring some sort of quality control change at a manufacturing facility for a drug that was never going to be produced (approved).

     

    The question then is how long? and at what cost? - for ALXA to be able to satisfy the FDA inspector.

     

    Any extra cost/cash burn has to be factored into the stock price very short term, but if issue easily correctable in short time/low cost, shouldn't really affect all that much longer term, and certainly not news that appears to warrant nearly halving the stock at this point.
    4 May 2012, 09:03 AM Reply Like
  • richwillard
    , contributor
    Comments (49) | Send Message
     
    The chart on this stock looks like it is in the final stages of resolving a bull flag pattern. I am looking for a move up by June 1st that will gradually fill the gap formed after the FDA rendered their decision. I completely agree with the idea that this FDA response is a proxy for approval, and we are presented with a buying opportunity at these levels.
    28 May 2012, 03:08 PM Reply Like
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