Typically, this happens for game changers. This is proof positive that the FDA will finally take this treatment seriously, and expose themselves to the light of day. The Adcom will be overwhelmingly positive, patients will be able to speak out, finally - and there will be NO EXCUSES for non-approval. They won't be able to hide behind closed doors this time. There are ZERO negatives here.
Yes, I failed to mention, you are correct, for game changers, there is almost ALWAYS a committee meeting, that happened by Tysabri for ELAN Pharma a few years ago with their novel treatment, the drug was approved and the share went over $20 after trading as low as $2 on near bankruptcy.
What I'm concerned about is the real possibility of the FDA being available to the highest bidder or subject to "influence" as is apparently almost every other part of the current administration.
For those of you that may be long and positive on MNKD like I am here is my suggestion of what I did to address my concerns about the FDA's approval process and lack of transparency, and to address the concern about what the needle injected insulin industry players and Wall Street types like Shkreli are trying to do to derail Alfreeza or play it short. If you believe in the power of a free press and your one voice counts do like I did and write a polite letter to the FDA and just let them know your supportive of MNKD and that you are watching the approval process develop. I also referenced the 2010 Shkreli letter writing issue where he sent negative letters to the individual FDA voting board members. As they say "the whole world is watching". Let them know we are watching. Your one voice counts as much as Shkreli's and the Nova CEO's does.
Sentiment: Strong Buy
Sadly, you are completely incorrect as regards the inference of an advisory committee being "proof positive" of FDA approval. First - there is no guarantee of a fair committee, second - there is no obligation for FDA to follow even a unanimous committee finding. This requirement, which is totally unnecessary btw, may be just their cover to disapprove or to clutter up the label if they do approve.
The committee meeting typically means, that there will maybe be some sort of label statement modification or warning, or that further post vigilance studies be conducted after approved, or the product will be recommended as a secondary to injections.
Typically it means there will be approval in my opinion, just with a dilution of the marketing impact int he short run, however this has happened in the past.
They will probably take into account patients opinions, and independent MD advice.
The may mitigate the revenue only in the early stages of sales, but should clear up after a few quarters of sales and further safety data.
This is just my guess, i could easily be wrong ! but its worth holding for sure, and i would suspect the shares will still rise above $20 after approval and eventually grow over time.
And by the way, this IS absolutely necessary - if there were no ADCOM, we'd have a lot more to worry about. You either haven't been in BioTech long, or you don't understand the progression of a game changing medication through the process. It would have been highly suspect if we didn't have an AdCom, in the case of a drug that is positioned like this one. I've been doing this for almost 10 years, and I'm very stoked about this turn of events..
I agree wholeheartedly. Management has been playing this one perfectly. If they indeed requested an AdCon, it's a brilliant tactic. Shining the light of day on FDA practices concerning this drug ameliorates any shenanigans the shorts and hedgies might try to play with it.
I do agree with you that having an open hearing on the record- if they recommend approval helps to counter act some of the monkey business that happened last time with the hedge funds.