FDA Plays

[pcrutch]

Some thoughts on Depomed

1- Just based on ABT's action, I have a very high inclination it will be approved. ABT is the one in charge of discussions with the FDA so far, they came to the conclusion DM-1796 would be approved, hence why they are trying to get the contract renegotiated.

2- Odds of delay on approval seem very small. Gabapentin has been around over a decade and its properties are well known. Depomed's tech uses Generally recognized as safe (GRAS) polymers in their Acuform technology.

3- I am long on approval since they were able to prove their technology's utility in diabetes with Glumetza; the bar for approval seems to be much higher there than other areas.

send me an email for the Roth and Caris reports on Depomed -- [e-mail]