Technical question:
I have a technical question, this is to anyone, long or short.
We all know that zonagen's phase III results show vasomax was effective for 51% of the men, 75% of the time, vs. placebo at 38% effective (also 75% of the time?) [I would have quoted from the Zonagen press release, but it was removed from my source]. This information was released on June 2 by Zonagen. Investors did not like these numbers, and the stock lost one third of its value. I have asked scientist friends about these numbers and I have gotten some chuckles but no real definitive answer about the numbers...to this question:
Does anyone know what the FDA's past practices on approval are when comparing result to placebo result? Has any drug, with 51% vs. 38% for placebo, gotten approval, especially *after* they've given approval to a drug with better results?
I REALLY WANT TO KNOW.
While this might sound like a posed short question, if someone would point out drugs which got approval with these numbers, I think that shorts should beware. If someone could show an FDA pattern of disapproval of drugs with small increase over placebo like vasomax, then longs should beware.
Forget the hype, I really don't care if Asensio or Podolski is a crook. I don't care if Viagra is dangerous, since I strongly doubt that the FDA takes that into account when studying vasomax, unless they plan to take Viagra off the market, which has zero likelihood.
One person on yahoo said that stomache upset helpers, like pepcid, did barely better than placebo. Is this true? If so, what is the significance?
If you know anything about fda approvals and do not want to be hassled here, email me at msk914@yahoo.com.
And one more question: What is the guess on this qtr's earnings?
Mark |
