Claud B, Most NDAs are review first by "the advisory review boards", and the FDA is not bind to their recommendations. Check ORG, ATIS, ERGO, PARS, LGND'Ontak, IMNX, and many other companies recent examples of going to the "panel review". I do not remember if Viagra went via a "panel review", I will say yes they did. I could not find the info.
Anyway, I was suggesting that short term possible positives news for Zonagen could be:
1. Acceptance of the NDA, (few weeks from now).
2. "recommendation for approval" by an advisory board to the FDA, usually before the actual FDA approval.
3. Fast Track designation.
Fast Track is just a bureaucratic design, it is actually financed with money pool by the drug industry to expedite their needs. The public is served because no tax dollars are involved and the obvious fast availability of a new drug.
If Schering is willing to fight for fast track (I think they indeed will) increases the chances for Zonagen.
For a short, again, better to get out at the recent low levels, and wait for a major definition of the status (less risk, less gain), and go short again later in the mid $20s (I think achievable with any of the above possible positives). For a Long, the opposite.
Finally, Claud B if you think that Viagra did not got a "panel review", please find the information and post. Do your DD again. |
