Adcom - April 1st

[mannmade]

Also does anyone know how the testifying experts are selected? As we know there are many pro Affrezza experts such as Dr. Skylar…  Also wanted to add that this may actually be seen as positive once digested by the market.  It moves up the decision date I believe by 14 days and consequently the coming build up in value will start earlier if it has not already. And we know outside of a few investor types it seems to be heavily supported within the medical community including JDF (Samsun Artificial Pancreas) so may actually separate fact from fiction.  JMHO...

[alcc]

The best case interpretation for Adcom is that the FDA wants guidance re expanded labeling. But sure does complicate things if some members might feel there is need for additional data etc. Sort of like a trial by jury. How smart/rational are the jurors? Read below article re Merck's Suvorexant and weep:

www.newyorker.com/reporting/2013/12/09/131209fa_fact_parker

[babaoriley]

Jan 10, 2014 8:38:45 GMT -5 brentie said:

Jan 10, 2014 8:21:39 GMT -5 savzak said:

I'd appreciate any opinions as to whether the scheduling of an advisory committee review is likely to affect the likelihood af a partnership in the near term.

Thanks.

I don't consider it a positive for partnership. It may be just one more question a potential partner wants answered before signing on the dotted line. I hope I'm wrong.

While certainly not a positive, my view is that if a deal were going to involve a $200,000,000 up front payment (most of which would be held in escrow pending approval), the portion of that which would have been released immediately to MNKD, as earned whether or not they get approval, falls from say $25,000,000 to $10,000,000.  Perhaps the BP would be inclined to spend slightly less money preparing for the launch, too. 

This is a gift to those who need to cover, and there are more than a few upset shorts who covered yesterday - LOL!  Just based on what I've seen from the price action today, it seems some more short covering may have kicked in and thus halted our slide.  But stay tuned, we are on loose footing!

[rak5555]

baba - Been meaning to ask - is that a self portrait?

I emailed IR and asked about the timing of the PR announcing adcom and whether it was part of the 74 day letter and what else may have been contained in the letter. Per management, they were advised of the adcom yesterday. It was not part of the 74 day letter which had been rec'd earlier. The 74 day letter did not contain any material issues.

[babaoriley]

rak, no, it's a quick sketch made by my 15 year old grand niece who my wife and I love dearly!! I don't look quite that goofy, but I have to admit, it's a decent caricature and it captures a bit of my essence!

Thanks for posting re IR response, a big, big relief. My worst thoughts this morning was that the adcom info was contained in the 74 day letter, but had not been timely released - I could see the lawsuits piling up like jets into LAX on the Wednesday before Thanksgiving if that were the case!

[oracle]

Interesting that the AdCom wasn't included in the 74 day letter. Maybe one or more BP's not happy that Al didn't pick them? And/Or the Director at FDA is just wanting to CYA and it does give credibility to the process. here's a link for more info.  www.fda.gov/ForConsumers/ConsumerUpdates/ucm048040.htm

Can't wait for Monday morning to find out who's buying us, my bets on Phizer putting their cash to work.

[rak5555]

The following from oracle's link: An advisory committee lends credibility to the product review process and provides a forum for public discussion of certain controversial issues. The process helps air issues that do not have simple answers. For specific products, advisory committees consider the available evidence and provide scientific and medical advice on safety, effectiveness, and appropriate use. Committees might also advise the agency on broader regulatory and scientific issues.

As I dwell on these words, I am drawn to the phrases "certain controversial issues" and "safety, effectiveness, and appropriate use". I am fairly confident that we have met safety requirements. Seems if there is controversy, it is about effectiveness and appropriate use across different types of diabetics. I think we are back to the old armamentarium issue, which is, how does Afrezza fit into the array of diabetes treatment options available to physicians? The answer to this will drive the label. I suspect the FDA is reaching out for help w/ this issue.

[spiro]

Rak,

By it's proven ability to reduce instances  of severe hypoglycemic events, as compared to other insulins, Afrezza will save lives in both type 1 and type 2 patients. This will be an easy sell to an advisory committee.  Bring it on. 

[babaoriley]

Today's news will be but a blip in a few days. This is nothing to worry too much about, IMO, and we will soon learn to live with it. On the other hand, the FDA, well, I still worry, but the addition of this committee should not make approval materially less likely. And if the Committee actually is impressed with Afrezza, then an overwhelmingly positive recommendation by the committee might help us with the FDA slightly. Having said that, I clearly wish we just had the FDA (and AF) to deal with.

Does anyone know whether these committees actually ask representatives from the applicant company to come before them to discuss/answer questions or do they go through materials prepared for them by FDA staff, discuss with Staff and then, finally, hold their public hearing, and shortly thereafter, render their recommendation? I believe that once a committee is chosen from the committees available to the FDA, there is disclosure as to the members thereof. And, at that point, I think it's possible to review the history of the committee members' past recommendations (not dissimilar than checking on cases decided by your trial judge or appeal panel). I seem to remember that with respect to AdComs, but am not 100% certain. I'm sure it will all be discussed in detail here over the next couple of months.

This was one of the most interesting weeks of all to be a MNKD shareholder, and if you remove those interesting weeks that were disappointing, then this week stands out even more.

[rak5555]

The following cut/paste post from dreggy on the "other board":

For those holding through the AdCom, you can get the live webcast of the meeting at FDAlive.com. The stocks I have held during these events have all been halted the day of the meeting. You get a good picture of the drug approval process, with all the pros and cons at these meetings. Unfortunately not all committee members are up to date on the particular drug being discussed that day, which was surprising to me the first few I watched. The cost of the webcast is usually $140.

Endocrinologic and Metabolic Drugs Advisory Committee Roster

Designated Federal Officer
Karen Abraham-Burrell, Pharm.D.
Division of Advisory Committee and Consultant Management
Center for Drug Evaluation and Research
Food and Drug Administration

William R. Hiatt, M.D., FACP
Expertise: Cardiology
Professor of Medicine
Division of Cardiology
University of Colorado School of Medicine
President, Colorado Prevention Center (CPC) Clinical Research

Vera A. Bittner, M.D., M.S.P.H.
Expertise: Cardiovascular Disease
Professor of Medicine
Section Head, Preventive Cardiology
University of Alabama at Birmingham

Erica H. Brittain, Ph.D.
Mathematical Statistician
Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases (NIAID)

David W. Cooke, M.D.
Expertise: Pediatric Endocrinology
Clinical Director, Division of Pediatric Endocrinology
Director, Pediatric Endocrine Fellowship Training Program
Johns Hopkins University School of Medicine

Edward W. Gregg, Ph.D.
Expertise: Epidemiology in Diabetes
Chief, Epidemiology and Statistics Branch
Division of Diabetes Translation
Centers for Disease Control and Prevention

Diana Hallare, MPH
Expertise: Consumer Representative
Term: 08/22/2013 - 06/30/2017
Visalia, California 93277

Mads F. Rasmussen, M.D., Ph.D.
Expertise: Pharmaceutical Medicine, Endocrinology, Diabetes and Obesity
Project Vice President
GLP-1 and Obesity – Global Development
Novo Nordisk A/S.

Ellen W. Seely, M.D.
Expertise: Endocrinology, Metabolism, Diabetes
Professor of Medicine
Harvard Medical School
Division of Endocrinology, Diabetes and Hypertension

Robert J. Smith, M.D.
Expertise: Endocrinology, Metabolism
Professor of Medicine (Endocrinology)
Alpert Medical School of Brown University
Ocean State Research Institute

[alcc]

I urge anyone interested in how an adcom operates (I assume everyone here) to read the following very interesting article.

www.newyorker.com/reporting/2013/12/09/131209fa_fact_parker?currentPage=all

The FDA poses a set of questions to the committee, including ones re safety, sufficiency of data, scope of label etc. After hearing presentations from the company experts and asking a bunch of questions the committee takes a vote on each question. Simple majority governs. Does not appear to be merely advisory. In other words, it appears the FDA will simply adopt adcom's decisions. The problem is, imo, whenever you have a diverse group of people they will bring their ideological biases to the table. Plus, it's not skin off their nose to ask for more tests and more data.

Overall, this is not good news. I'd say greater than 50% chance they will ask for more tests, which means in-complete response and re-submission. Otoh, hard for me to believe a majority of experts will flat out vote to reject.

[thsloppy]

My 2 cents is agreement with Rak...I think this will be more about appropriate use. I think efficacy and safety will be quickly answered. The question is what does the indication for use look like. I think the expansion of label is why we have to have an adcom.

[alcc]

McKinsey report on use of Adcoms >>

www.mckinsey.com/~/media/McKinsey/dotcom/client_service/Public%20Sector/Regulatory%20excellence/FDA_advisory_committee_outcomes.ashx

[oracle]

Nice try alcc, after reading your referenced article, I wouldn't vote for approval either. It's not even relevant as psychotic drugs are very subjective unlike physical enhancing drugs. Exubera was also reviewed by a Advisory Committee. That said, Phizer's been there before and wouldn't be a deterrent from them acquiring MNKD.

[ezrasfund]

I notice that there is no specialist in Pulmonary Medicine listed on the advisory committee, which seems to indicate that lung function is no longer an issue. I have to believe that the AdCom this time around is about Type 2 diabetes and the fact that Afrezza may be much more widely used than under the original NDA's.