Elan: what could go wrong? ZT

Fresh off the Yahoo BBS, I am feeling so giddy.....



What could go wrong...
by: jtinformed
Long-Term Sentiment: Strong Buy 11/21/04 11:04 am
Msg: 480895 of 480966

Having worked for the FDA and being quite familiar with the regulatory review process let me just make some comments about possible outcomes this week for Antegren. We all know that the safety and efficacy results for Antegren have been stellar and company officials have been stating consistently that they expect approval by the end of this month so what could go wrong? My biggest fear and one that I think is barely worth mentioning, is if something adverse was found with Antegren use over time ie, decrease in effectiveness or new adverse reaction profile (less than .01 % IMO). A more likely scenario would be disputes on labeling content. As I recall this is what happened with Prialt and the company decided it was not worth marketing until they got the more favorable labeling which is why they did the additional trials. I put this possibility for Antegren at about 5% and would result in an Approvable letter.Finally, based on my evaluation of the available data and what management has consistently stated I put unconditional approval at 95% probability. Further, whether appovable or unconditional approval the data will be a key element in moving the pps. Won't be long now! Regards,JT

所有跟帖： 

• Price target if approved -funnyornot- ♀ (230 bytes) () 11/21/2004 postreply 11:05:55

• $40 by nextMarch. -crossfinge- ♀ (436 bytes) () 11/22/2004 postreply 06:38:27