This drug approval deserves lots of press this weekend.
Company is awefully quiet. Something else brewing? T1 code still up.
Just noticed that FLML has a pdufa date of April 30 - and they have not had a press release either today.
The entire reason the NDA submission was delayed was so that they would be ready from a manufacturing standpoint. If there's a CRL related to that - many heads should roll.
FDA wants this drug out there - and they know ACAD doesn't have the sales force to get it done in a lightning fast manner. No BB warning makes it a very juicy takeover target for one of the big pharmas that has an established sales force.
Agree with all - except that I think there will be a press release on Friday. The last few PDUFA weekend dates that I've tracked have all had a decision released on Friday.
Extremely volatile the last 20 minutes of trading - with huge volume spikes. We'll see if there's news after hours.
Elizabeth Mittendorf presenting:
Saturday April 16
4:15 pm - 5:15 pm
So you agree that there won't be a halt for futility? That means Neuvax is working.
What happened to the 100K you were short at $0.80? Got nailed on that one - right?
There will be no publishing of interim data. From the FDA protocols:
The execution of an interim analysis should be a completely confidential process because unblinded data and results are potentially involved. All staff involved in the conduct of the trial should remain blind to the results of such analyses, because of the possibility that their attitudes to the trial will be modified and cause changes in the characteristics of patients to be recruited or biases in treatment comparisons. This principle may be applied to all investigator staff and to staff employed by the sponsor except for those who are directly involved in the execution of the interim analysis. Investigators should be informed only about the decision to continue or to discontinue the trial, or to implement modifications to trial procedures.
I challenge you to find the last drug with an unmet need that was rejected by the FDA after a positive ADCOM vote. Good luck with that.