Marshall
I've been lurking on the thread and continue to appreciate your contribution.
There is an interesting paragraph in the press release (FDA Responds to Premarket Approval Application, 6/11/98)
First paragraph:
"Separatelly, the FDA also suggested that a Treatment Investigational Devise Exemption ((IDE) be submitted. The IDE is a new regulatory provision for devices that permits companies to make available promising new products under an agreed clinical protocol to patients with serious diseases for which there is no satisfactory alternative."
Has the FDA "suggested" that ATIS offer Dermagraft for sale while the new trials are taking place? Is this a way for the FDA to save face and clamp down on retrospective analysis (Someone on Yahoo thread made the plausible argument that the denial was based on the FDA's concern over setting a precedent by accepting retrospective data analysis) while at the same time offering back-door approval?
If this is the case, the fall to $4 is overdone. But, if this is not the case, and the IDE is of little consequence, then the situation may be as dire as many express.
A post on the Yahoo thread suggests that we average down. What are your thoughts? I placed a call to Smith and Nephew yesterday, but Chris O'Donnell was unavailable.
Tomorrow I travel to Paris for research and then to Germany for a conference, so I will be out of touch for two weeks. May try to log into the web to catch up on this thread.
If you or one of the other posters would call S&N, their view would be important. Tel number is 011 44 171 8367922. By this time, S&N must know if Dermagraft is effective (therby confirming the studies)or not, and how they feel about a potential 2-3 year wait for US sales to materialize.
Major concern, of course, is how ATIS obtains funds to see them through this period. If IDE sales are permitted and if they are somewhat substantial, burn rate becomes less of a concern.
Did we all just loose a ton of money, or do we have to wait a little longer for the trip to the bank? My view is that the wait will be longer, but I don't have a good record of late on biotechs!!!
Regards
Barry |
