No - this company has a binary event now scheduled for August 7th. If you review the last ADCOM meeting, it was a complete fiasco. Oli should have been approved, if it weren't for several of the panel members not doing their proper review ahead of time. The vote was 8-7 against approval. Of the 8 who were against approval, 4 were seeking a few extra data points (some which were actually in the presentation which was later discussed) and some that required additional QT testing. The QT testing has been completed and has met the FDA guidelines for resubmission, which is why it was accepted. TRVN has done everything by the book to get back at the table for another review.
Also, it should also be known that those 4 members wanted to vote "yes" but wanted that QT testing confirmed to ensure safety. The results has proven just that.
FWIW
If TRVN gets left at the alter again here, we then know that politics come into play and science isn't truly prevailing which is a disgrace to our country and for the population that could benefit from an alternative to morphine. Surprisingly, a % of the general population has adverse side effects to morphine.
For those that are hinging on the debate of "we don't need another opioid on the street" - please remember that Oli is IV-based and their GTM model has specific hospitals and pain centers lined up for commercialization.
At .78, I feel this is still a bargain... and the risk/reward is significantly slanted toward greater reward. Regardless, this should run-up a time or two prior to the lead-up to the August ADCOM.
