I'm very long and very hopeful for positive interim results. A halt for futility, although unlikely, could cause the pps to crash below $0.50. Any suggestions for hedging a large long position using options or other means? Option premiums just seem very expensive from what I see.
IMO the longer we go without an announcement - the less likely that we will have a halt due to futility. You can run the statistics on the results in 1-2 days. Anything longer than a few weeks suggests that they are working with the FDA on potential accelerated approval (or halt for efficacy if results are really good).
I'm not questioning his technical background. But I would take with a grain of salt any opinion from someone who has almost no experience evaluating past drug launches. Plus - he has a spelling error on his LinkedIn profile - that makes me question the thoroughness of his research and his attention to detail.
Given all that - I'll grant you that management dropped the ball on the call.
Look up his LinkedIn profile. This guy was a chemistry tutor only 5 years ago:
Director, Biotechnology Equity Research, Leerink Partners
June 2012 – Present (4 years) Boston, MA
Senior research analyst covering smid cap biotech stocks, with a primary focus in neurology, CNS and infectious disease.
Researcher, Harvard Medical School
August 2011 – June 2012 (11 months) Harvard Division of Sleep Medicine, Brigham and Women's Hospital
Organic Chemistry Tutor, Skidmore College
January 2010 – May 2011 (1 year 5 months) Saratoga Springs, NY
They didn't buy a ton of shares in a secondary BEFORE approval without a specific plan to make big $$ after approval. Hold tight and give them a few months to work their magic.
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.