One of the reasons for the delay was the dosing MNKD submitted in the NDA is different from the dosing in the trial. The procedure would have been for the FDA to ask for more information as to why they should approve dosing different from the trial. The response would be for MNKD to submit more information supporting their position. The FDA will have to review this and consult with experts in the field. Then they may need to ask more questions. This is just one of the several issues that may need to be resolved. REMs would certainly be another. MNKD would be asked to draw up a REMs plan. Lung testing, Plant inspection, device handling, etc., etc. The sooner these are resolved, the sooner the approval will be made. Remember, the last time the FDA extended the PDUFA date was for 1 month - the result, a CRL. If their intent was to issue a CRL, they would have taken a 1 month extension. 3 months is a bona fide effort to resolve outstanding issues. And it may be resolved sooner.
vcpaddler, what would a partnership mean a few years ago if the result was a CRL? Nada. Just means you could have sold and bailed out sooner. Do you think this may have been a consideration by the board of directors?
Yes, there are many. The FDA has a lot of freedom on this. They have written letters before the PDUFA date saying they intend on approving; They have approved within a few weeks even with a 3 month extension. It is actually more concerning if it goes the full 3 months and specially concerning if another delay is announced. That means they can't resolve some issues.
Cramer on support obvious winners. He's hardly an analyst - more like a reporter. He won't say a stock is good until it's good. Good for talk shows, not good for investing.
hmmm...do you think a partnership could be announced before or during the meeting? How about FDA approval? What's the chance of that? It be a toned down shareholders meeting. MNKD officers waiting for their options to vest. Shareholders wanting for more info. But hey, you never know!
rambleon, 'i didn't know that legal action was taken against Shkreli.... was there ever any resolution..?' - there was an investigation but no formal legal action. Subsequently, Shreli quit his hedge fund and started his own biotech. I've been through similar investigations (it's part of my job) and I know it can be nerve wrecking when you potentially could spend time in jail. So my guess is Shkreli decided that was a close call and decided not to do it again, or that there was an out of court settlement that he no longer engage in such activities. Just a guess.
clevans1, unfortunately those statements are correct:
1. "They used a different algorithm and now want an algorithm that wasn't used"? - this is correct. I warned about this even before the adcom that this alone couldbe reason for delay of approval.
8. "171 was statistically non-inferior but numerically inferior"? - also correct. But it meets endpoint which is all that matters for people who only care about stats
11. "Enhanced pre-malignant bronchial and/or lung lesions". Don't remember this but since the first two are correct, it is probably also correct. But don't take it out of context, whenever this is raised it is always for people who are smokers or COPD.
Here's another one from the Shareholders Meeting:
"Our executive compensation program emphasizes pay-for-performance. As described below, it is premature for our short term and long term incentive plans to be tied to financial metrics; accordingly, the metrics are designed to encourage our progress through the FDA approval process and our ability to obtain a partnership and to develop a candidate for commercialization. The compensation package for our executive officers includes both cash and equity incentive plans that align an executive’s compensation with our short-term and long-term performance goals and objectives."
Kevin, you'll like this:
"Each such annual equity award shall vest in 36 equal monthly installments commencing one month from the date of grant; provided that, with respect to any such equity award that is granted prior to the date of approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application submitted by the Company for AFREZZA (the “FDA Approval Date”), no vesting shall occur until the FDA Approval Date, at which time any portion of such award that would have been vested as of such date absent this proviso will immediately vest."
So I guess the MNKD officers would like the FDA approval asap as well.
seyhey, I agree with you. Al first commented about the adcom in September, just one month after NDA submission. I don't think the FDA could have figured out anything 1 month after receiving a submission with 3,000 pages of supporting data. Furthermore, they received the first letter from the FDA without mention of the adcom and then received a follow-up letter with an adcom. That was probably because of MNKD reminding the FDA of their request for an adcom. If I were Al, I would ask for an adcom as a risk mitigating measure.
I've been in a stock where the FDA announced an extension and then in a few weeks announced approval. 3 months is just the standard extension but they can decide to approve anytime. Perhaps the extension was to accommodate the BP to attend the labeling discussion with the FDA. Hey, you never know!
kevin, Al said he will not make the announcement on April 15 so he can see your reaction. He gets a kick reading your posts.
Kevin, I agree the salaries are fairly large for a company with no sales yet. However, when you look at the opportunity cost - Al could have placed his $1B in a money market account and earned 1% which would equal $10M per year. So is paying him $5M for his time and money too much? If MNKD paid Al the same rate as Deerfield's 9%, that would be $90M/year. I agree about the others - they are overpaid for what shareholders have gotten so far. But they could easily make that same salary somewhere else.
I think the difference is being a trader as opposed to being an investor. Anyone investing already knows what you are bashing about. If they don't, they don't belong here or any biotech. Anyone who has held long enough ought to look back and see all the odds they have already been through and to sell now, just before the big bang would be like quiting just before the finish line. If you were cautious you should have sold before the adcom vote. The risks I was afraid of - that Al was not disclosing bad things or misrepresenting the trial outcome - is now gone. There are still risks that is why there are still big returns to be made.
And what are you doing in biotech? You should be in Cash or CDs.
'The FDA can damm well do what they please' - If this was true no one will be investing to develop new drugs, let alone invest $1B - $2B to get a drug approved. There is some sanity to their methods. You just don't know it or care to know.
The response from another board is that the FTC filing maybe due to the conversion of debt to equity by Al to match the ATM ($50M) to retain his 45% ownership. I don't buy this explanation because that does not require filing since he is not increasing his ownership%. Another post pointed out that the same Termination Notice was made in Feb 2011 (right after the 2nd CRL).
My speculation is that he is potentially merging another business into the Afrezza mix to make it more attractive and that could be the "pump" he is developing under another of his company. The new basal pump and AFrezza together may be the complete package. Just a speculation.
One thing is sure. Everything is going reverse of the last time. So the last time Al filed a merger notice nothing happened. Maybe this time something is really happening.
Anyone knows when the investor conference is for 1Q 2014? What about the annual shareholders meeting? anyone has the date for this? Is it going to be before the July FDA approval?