The FDA must be the most corrupt organization in the world. How dare they have the audacity to say they did not have the time to review the data, which ultimately caused many investors to lose mega bucks due to their incompetence. I wonder if they made mega bucks shorting.
They should fire the commissioner and have an outside company revamp the remaining organization.
I hate to think that my taxes fund an organization such as this.
Something odd is going on with indiplon.
Originally the PDUFA date for the 15 and 20 mg ER tablets was June 15. Then NBIX and the FDA came to an agreement that they would be reviewed together, and the May PDUFA date for the 15 and 20 ER would be pulled ahead to the May 15 PDUFA date for the 5 and 10 IR.
Then the FDA says they didn't review some data that NBIX submitted late, after their submission (when all the data is to be reviewed is suppose to be submitted), during the review process.
Typically, the FDA would talk with the company and they would get an agreement to slip the PDUFA date so that all the data could be reviewed.
So the question becomes, did the FDA not request NBIX to agree to a PDUFA date slippage, or did NBIX "pull a boner" by refusing to slip the PDUFA date at the FDA's request?
Since the FDA performance is graded on meeting the PDUFA dates, and they are not obligated to review data which is submitted late, obviously, if NBIX would not agree to a mutually agreed delay, the FDA would just use the data included with the submission and meet their PDUFA date obligation, rather than include the late data submission, miss the PDUFA date and get a bad performane mark.
Did NBIX try to play hardball with the FDA and, in the process, screw themselves?
It would be quite interesting to know the details.
> Did NBIX try to play hardball with the FDA and, in the process, screw themselves?
Yours is the best post about this debacle that I've yet seen on this board, and I think your suggestion is the best-fitting explanation for a baffling situation.
The question now is what the prognosis is going forward. The solution obviously is to play ball with the FDA (We over at ELN have been doing this for a year and a half now, trying to bring Tysabri back. It's a painful discipline but it's the only way to succeed.) But how will this map out and how long will it take? Will it entail an entirely new NDA, or just an sNDA? Seems to me we will have a couple of months, at the least, to speculate about it.
Yes - the FDA is completely corrupt. Look at other stocks & companies that have gone through what you guys are going through: ENCY, NPSP, and now DOVP/NBIX.
Search on the words "FDA" and "Corrupt" on google and you will be shocked at what you find.
"Search on the words "FDA" and "Corrupt" on google and you will be shocked at what you find."
Yeah, search on the words:
tap dancing islamic fundamentalists
And you'll also be suprised at what you will find.
The internet is like a big City -- theres lots of garbage around if you look for it.
"The Fda is a joke and puppet for Big Pharma who does not want any comp from small biotech.."
PFE is "Big Pharma" and wanted the approval badly, as they need every product they can get.
Your thesis, at least in this case, is quite flawed.