2014 Advisory Committee Meetings
May 6, 2014: Risk Communication Advisory Committee Meeting Announcement
May 5, 2014: Risk Communication Advisory Committee Meeting Announcement
April 1, 2014: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
March 31, 2014: Anti-Infective Drugs Advisory Committee Meeting Announcement
March 27, 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
March 26-27, 2014: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement
March 20, 2014: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
March 20, 2014: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
March 18-19, 2014: Blood Products Advisory Committee Meeting Announcement
March 14, 2014: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
March 12, 2014: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Almost hard to believe the long wait is finally coming to end and for the first time ever real facts about Afrezza's future will be out known.
The two company's have been interacting with each other since 2009 and they even have agreements established between them for insulin and one that transitioned Exubera patients onto Afrezza. Pfizer spent and lost money establishing the ground work to get an inhaled insulin drug approved around the world, albeit they chose the wrong product to be successful commercially and I may be wrong, but I believe Pfizer has been keeping an eye on Mannkind ever since 2009 because they still have the same vision and goal that an inhaled insulin drug will dominate diabetes and become a super mega blockbuster that will exceed the results they were able to achieve with Lipitor. Pfizer has close to $50 billion at their disposal and they could have used some of that money to offer Alfred Mann financial terms and a commitment to make Afrezza the next Liptor in order to buyout Mannkind. Pfizer already has egg on their face from Exubera, so I expect they aren't going to rush into finalizing a deal until all the i's are dotted and t's crossed in the United States having an FDA approval in hand. Just one possible outcome, but I think it's high on the list of possible outcomes.
How much longer ?
I actually posted a comment on the SA article to George about adding the JDRF study as a 3rd party review requirement for anyone doing DD.
The FDA has previously completed a 10 month NDA review and a 6 month resubmission NDA review, so why did they decide to convene an ADCOM Meeting just two weeks before their scheduled PDUFA?
1) The FDA is convening the meeting to assist with final label and support the agency's approval decision
2) Mannkind asked for the meeting to make the review public and the agency accommodated them
3) A major deficiency or deficiencies were found during the 60 day review that warrants an ADCOM review.
Mannkind hasn't announced any deficiencies having been found and Mannkind also said the ADCOM Meeting was not part of the 74-Day Letter they received. This may suggest the meeting is just a formality that Mannkind either insisted on or the agency wants in order to help them with final label and/or to cover their final approval decision that's coming out two weeks after the meeting. One thing is for sure a two week gap between an ADCOM Meeting and a PDUFA date is unusual. I just hope the FDA is not once again playing games assigning an ADCOM Meeting so close to the PDUFA date just to allow them to extend the review timeline past 4/15. Most of us were expecting and hoping the FDA would first issue a Class I two month review which didn't happen and next we were hoping the FDA would issue an early decision before 4/15 which is not going to happen, so the best case scenario will have the ADCOM Meeting happening on 4/1 followed by FDA approval on 4/15.
My apology to kevinmilkthecrazyman you actually celebrated your 6 day anniversary today. Be happy you lasted this long.
kevinmilkthecrazyman I first want to wish you a happy 4 day profile anniversary since you created it on March 4th and now want to wish you a found farewell, as you get added to my ignore list. Keep your juvenile responses coming because it just reinforces how desperate shorts are becoming and the bigger my ignore list gets the better. Now goodbye for now until your next profile shows up.
Mannkind's two recent investor conferences had zero information about Mannkind's commercial strategy and they have stopped using the word "Partnership". The new position Mannkind is taking is to just acknowledge they are happy with Greenhill, but they don't say what they are happy about. The company has nothing to lose to reinforce that Greenhill is still focused on partnership, but they don't even do that. I expect Greenhill has completed their work and delivered either a partnership deal or more likely a buyout deal that will be announced after ADCOM or together with an FDA approval announcement.
I hope Yahoo doesn't have a limit on the number of dirt bag shorts I can add to my ignore list, but getaglue rest assure you have been added to the list.
Greenhill negotiating a formal partnership process was Mannkind's original statement, however, if you notice of late, Mannkind has dropped the word partnership from their communications and are just saying they are pleased with the way Greenhill is handling things. They have backed off talking about partnership during their recent investor conference presentations. It seems to me Mannkind is structuring towards a buyout and not partnership. JMO
1) Mannkind is holding out to get a better partnership deal after approval
2) Mannkind is holding out to start a bidding war buyout after approval
3) Big Pharma is holding out to see if approval happens
4) Mannkind has a partnership deal ready to go immediately following approval
5) Mannkind has a buyout deal ready to go immediately following approval
6) Mannkind & potential partners know Afrezza approval will be delayed once again
* my first pick is #5 closely followed by #4.
A unanimous or close to unanimous vote by ADCOM Committee to recommend approval all but signs, seals and delivers a guaranteed FDA approval. I just can't imagine the FDA will turn around and reject Afrezza after all the shenanigans that went on during the agency's last review and now having an ADCOM Panel strongly recommend an approval. An ADCOM vote that overwhelmingly recommends an approval will leave the FDA no choice but to turn around and issue a final approval quickly no later than 4/15/14. If however we see a waffle vote or waffle opinions coming from the ADCOM meeting, I expect it could force the FDA to extend the PDUFA date, however, I still believe the FDA will ultimately approve Afrezza. All eyes should be squarely focused first on briefing material when issued on 3/28 to see if anything unusually appear in the documents especially having to do with safety and to see what the agency's different departments that reviewed the drug like Medical Safety & Efficacy Officers opinion's are. Next up with be the ADCOM Meeting itself on 4/1 and the final vote count that will be a telling sign if approval is just around the corner on 4/15 or an extended review is about to happen. It should all be very exciting and I truly hope very rewarding for Longs....
Medtronic seems to be a common thread whenever the name Alfred Mann comes up including the new company that the Mannkind Foundation just announced that included the hiring a new CEO coming from Medtronic. A merger between Medtronic and Mannkind would create the leading innovative diabetes company in the world.
Mannkind's post approval buyout strategy obviously keeps any money from changing hands between Mannkind and the acquiring company and Deerfield is filling the cash void until the buyout is completed. Deerfield will be handsomely rewarded for their support after Mannkind is sold. I expect at the time Mannkind is sold post approval, Deerfield or insiders that Deerfield sold Mannkind shares too will have about 19 million shares in their possession all p,urchased at about $5. Ultimately those shares being sold at buyout offer anywhere between $15 to $35 dollars will have Deerfield or their insiders walking away having made a lot of money.
19 million x $15 = $285 million
19 million x $20 = $380 million
19 million x $25 = $475 million
19 million x $30 = $570 million
19 million x $35 = $665 million
At the time of buyout, Alfred Mann could have upwards of 200 million shares being sold. It will over night catapult Alfred Mann and his Estate to regain a top spot on the billionaire list making him one of the riches people in the world and it will give his philanthropic groups a boat of new money to support their medical research to improve the lives of mankind. I think Mannkind is as good as sold if not already sold just waiting for FDA blessing to sign the deal. I expect Mannkind will survive as a company after the company is sold as a subsidiary LLC Company to a large global player like Sanofi or Roche continuing their great work
200 x $15 = $3 billion in cash
200 x $20 = $4 billion in cash
200 x $25 = $5 billion in cash
200 x $30 = $6 billion in cash
200 x $35 = $7 billion in cash
Mannkind hasn't hired a single new senior executive that would be focused on managing a limited commercial role post approval or have someone in place to manage the inter workings for a significant new global partnership between Mannkind & Partner. There is nothing going on that says Mannkind has senior executives ready and able to work together with a new partner on a significant number of inter company objectives and goals and instead, they are only focused on the FDA regulatory outcome and to making sure Danbury Manufacturing Plant is ready to support commercial launch.