Use access key #2 to skip to page content.

ETFinnovators (< 20)

Updated FDA Calendar of Decision Dates

Recs

1

November 12, 2008 – Comments (1) | RELATED TICKERS: DSCO , DNA , XNPT

Updated FDA Calendar of Decision Dates

[web link to calendar of FDA decision dates]


The accompanying table of FDA decision dates 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.

1 Comments – Post Your Own

#1) On November 12, 2008 at 9:20 PM, milpo (99.37) wrote:

Dear InvestRx:

After this wave of develeraging,  nobody will be able to afford glioblastoma therapy.  We will just chalk it up to bad luck, make our peace with our creator, and be allowed to die a peaceful and natural death.  God!  How morbid. 

The drug companies have been ripping off American citizens since their inception.  R & D costs.  Bull!   If you cannot survive with the drugs available on the Walmart $4 formulary, then you should just die. Ironically, I think that life expectancy and  quality of life will only improve if all the drug companies go bankrupt.

Report this comment

Featured Broker Partners