DING - TO NEUTRAL CORNERS GUYS AND PREP FOR THE NEXT ROUND!!!
The whole FDA will not be deciding on this. It really comes down to one guy, Robert Temple, director of the FDA's Office of Drug Evaluation (the FDA is not a democracy where they take a vote). At this committee meeting and the one last June, Temple seemed far more sympathetic to Myotrophin than the naysayers on the committee. He also shot down one committee member who stated that the data presented to date are too ambiguous to allow approval of Myotrophin. Temple stated that this did not represent the agency's definititive judgment. If it did, he said, there would be no need to ask the committeee for advice. He had several debates with the naysayers on the committee tempering their opposition or casting the data in a more favorable light. Temple is the guy who is going to have the political pressure on him too. Plus, this particular panel has a reputation for imposing stricter standards than other parts of the FDA.
IMHO the fat lady ain't sung yet on this one guys and to assume that this drug will get approved or not is just that, an assumption. We will all know when the FDA makes a real decision, this has not happened yet - that's why they call this an "Advisory" Committee, they give advise. Can't tell you how many times I've seen high power consultants thanked for their advice and then promptly ignored. Anyone for flipping coins, the odds are similar to this companies prospects. Whether this is the best buy in price before the final decision, who knows, time will tell. If it goes, this stock will rocket, if it doesn't, this stock will plummet - in the meantime, you make the call!!!
If you want to read what really went down at the meeting, get a copy of BioCentury by calling 415/595-5333, faxing 415/595-5589 or emailing Marc Schmitter <mschmitter@biocentury.com>, and you can get it by email. They have a great write up in the May 12th edition.
DING, THERE GOES THE BELL FOR THE NEXT ROUND, COME OUT SWINGING, BUT NO LOW BLOWS OR POINTS WILL BE DEDUCTED!!!
Ain't investing fun?!?!?! Keep smilin'
Rocketman |
