my understanding is that they don't have to have MD's. Some are statisticians, PhD's, researchers-- these guys don't have MD's. That is the reason why they need advisory committee to shed lights. Not all drugs and delivery systerm can be expected to be fully undertood. MD''s have better understanding becuase they know the limitation to the human body and some degree of mechanism of action.
the FDA agents should all be MD's in my opinion. If they hire statisticians, then those guys should work only in the background, not when it comes to voting.
wasn't rumored that the manger to a hedge fund is the husband of the FDA head? Definately confleict of interest there. How can this be even allowed in America? NOw the shorts can enjoy 3 months of covering.
If I was Alfred Mann, I would announce partnership STAT!!!!! trap the shorts then comes FDA arpproval that will give a final knockout punch.
First mnkd needs to announce that they have competitive offers from various companies, then the actual acceptance of the offer. That's how I would do it to maximize my gains on pps.
Hold half of your position, don't look at your pps any more. Hold the other half of your funds that you are looking to invest in mnkd and wait for either buyout/partner and ultimately buy on July 14th right before FDA approval.
Adam FuktardStain eyes will be much much puffier than ever, from all those days of crying and getting beat by his fellow shorts.
last gift from Alfred Mann to society is that he will make all mankind shorts vomit, defecate, and urinate all in the same setting, coming from ONE news disclosure.
tick toc tic toc, buyout at $60/shr. $20 bil
i think what he's trying to tell you isn't so much the number but any portion of drug not absorbed from the initial inhalation gets absorbed later and can cause severe toxic effect of insulin.
Afreeza non absorbed portion, on the otherhand, becomes inactive so even it gets absorbed later from the throat or tongue, it doesn't add to toxic effect.
wouldn't it be nice if Al sells it at $20 bil? which is very probable, puts us at $70/sh immediately. Al Mann should work with the Chinese, they will buy him out!!!
with 25% of market share, puts mnkd at $25-100/shr. Only idiots sell this in the single digit. Idiots! The platform for Technosphere is even worth more than that. I wish Al Mann can live to 150 yo, so he can make me richer than Warren Buffet.
I agree that it's standard to need time to think of labels and post marketing studies but they have had the results to the studies 3 months or so ago; they don't need 3 months. Are these super slow FDA agents?
I agree with your number #7, the fact that Adcom had such a unanimous approval, partnership/buyout could be announced at any given day. Trying to time this game and hope to get in at $5, you may miss the run entirely! I choose to stay in and wait for approval and hoping to have a partnership in between.
there is some urgency there-- only 25 other drugs with same profile serving the same purpose.
yikes, husband is a hedge fund manager and she is the FDA director??? Let me guess, her husband specializes in biotech stocks. How can the government allow this to happen?
I always believed that the FDA played a fair and looking for the best interest to protect the public. But from what it seems here is that they want to burn mnkd to the ground. A lot of politics and probably funding of FDA from big pharma. I simply don't understand how the studies and data are available and have been discussed thoroughly with the Advisory committee to the FDA, these are doctors who give advices to the FDA. Are members of the FDA that stupid to require 3 more months to make a decision that has already been made by their Advisors??? They are reading the same studies and data as the advisory committee, why need 3 more months to decipher the same data? Crooks!!!!!
Here's a complete overview:
We have Alfred Mann who owns appx 92 mil shares, that is almost 1/4 of total share vol. So, I bet he has deep interest in stock price as well as the faith of where he is going with Afreeza. With that being said, mnkd hired Greenfield 4 months ago to look for the best partner or buyer. Since then we have not heard a word, but I am sure there must be interested party. The question is who, how much, and how come they haven't come forward and signed the deal?
Well, if you are the buyer would you want to get into something that gets rejected by the FDA? Obviously not. So what did mnkd do? They asked for Adcom, to a lot of investors this didn't seem to make any sense. Why would you want to put yourself in an advisory committee that scrutinizes the approval TWICE? That just puts you at more risk of getting rejected. And why need an advisory committee two weeks from the expected FDA decision on April 15th? Time frame is so short, two weeks apart? Why need Advisory committee? The answer: to prevent foul play by the FDA and to ensure stock price stability.
Mankind is one step ahead of the FDA this time, they knew exactly that the FDA would postpone their decision making from April 15th. What do you think would happen to the stock price if there was no Adcom's decision? The share price would probably be around $2-3/share right now after this FDA delay!!!! Adcom's approval of 27-1 helped Mnkd tremendously by stabilizing the stock price. At the same time, now the buyers and partners that Greenfield have been working with are more eager to sign that contract, knowing that the chance of getting approval is VERY HIGH. The potential partner may sign the contract on contingency of FDA approval. Ample initial funding to push forward the project. The FDA delay is more than just a delay, it's an action hoping to cripple mnkd in its track; they have all the studies to make their decision, it doesn't require 3 mons!