Updated FDA Decision Date Calendar

The accompanying table of FDA decision dates (click to enlarge) is updated to include the following:

1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK).

2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09.

3) Genentech (DNA) filed for accelerated approval of Avastin as a secondary treatment of brain cancer (glioblastoma) based on positive clinical trial results.

Also, the backlog of decision dates I wrote about last week still remains -- with only DSCO hearing back from the FDA on the decision to classify Surfaxin as a Class II review, which is probably more of a reflection of the agency's understaffed conditions rather than an issue with the complete response for the drug.

Comments

[andyn:]

Good list...
Is there a FDA website which lists the updates to the dates as and when it happens?

2008 Nov 13 09:06 PM

[Mike Havrilla:]

No FDA sites or free websites that I know of - that is why I maintain the list at my blog and post here at Seeking Alpha with updates:
ETFinnovators.com

2008 Nov 14 08:59 AM