Adcom Minutes

[seanismorris]

For those who prefer to read in addition to watch, blog, etc.

There are probably some hints to what the label will look like in here.  

Also, it's interesting what the FDA took away from the Adcom discussions..

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM397049.pdf

[seanismorris]

Something that could be a concern for investors:

Some committee members also expressed concern over not having adequate treat-to-target trials, and recommended having these trials conducted as they may be needed to confirm the efficacy in achieving targets with Afrezza. The committee mentioned that the study designs should be carefully developed to determine whether it should look at the use of Afrezza as a background with basal insulin being initiated first, or another construct on how Afrezza should be used.

My opinion is there is no way to have a clinical trial for every possible diabetes treatment scene rio, and the panelists would would like more data no matter how much data was provided.

Something positive:

Committee Discussion: Based on the pulmonary safety findings in the Afrezza clinical development program, it was the consensus of the committee that there was no particular reason for concern over the impact of changing the device from a safety perspective.

[hopetoretire]

May 18, 2014 22:45:55 GMT -5 seanismorris said:

Something that could be a concern for investors:

Some committee members also expressed concern over not having adequate treat-to-target trials, and recommended having these trials conducted as they may be needed to confirm the efficacy in achieving targets with Afrezza. The committee mentioned that the study designs should be carefully developed to determine whether it should look at the use of Afrezza as a background with basal insulin being initiated first, or another construct on how Afrezza should be used.

My opinion is there is no way to have a clinical trial for every possible diabetes treatment scene rio, and the panelists would would like more data no matter how much data was provided.

Something positive:

Committee Discussion: Based on the pulmonary safety findings in the Afrezza clinical development program, it was the consensus of the committee that there was no particular reason for concern over the impact of changing the device from a safety perspective.

-------------------------------------------

Uh....something else kinda positive, they all voted to approve Afrezza.  "Could be a concern" of shorted investors.    

[seanismorris]

I agree.  The 27 to 1 is very positive.  And, approval is just about guaranteed at this point.  The 'concern' is about how many additional studies is the FDA going to require.  For example, the one for younger patients doesn't bother me because it expands the possible market for Afrezza.  But, requiring many more study's could hurt Mannkinds bottom line.  It's also possible that doctors could wait until any additional studies are completed before prescribing Afrezza.  The costs of the additional studies will hopefully be part of the partnership agreement.  Could this deter potential partners?  I don't think so, but you never know.  I'd like to see Mannkind become quickly profitable after releasing Afrezza so they can fund other Technosphere drug prospects.

FYI

I'm not a Bear (very much the opposite) but I think understanding the bear case for MNKD is important.

Here is the bear case as I understand it
1. MNKD is more than fully valued
2. Afrezza isn't as good as injected insulin at lowering A1c
3. Doctors didn't support Exubera for the treatment of Diabetes and Afrezza is just another inhaled insulin 
4. The Post approval studies are expensive and funding more studies will wipe out MNKD market value
5. Mannkind needs a partner to make Afrezza a success and they don't have one

As investors in MNKD we should all be able answer (reply intelligently) to these statements.  The reason MNKD sold off (in the FDA scare) in the day prior to Adcom, is because many investors didn't do their research...  

[jpg]

May 19, 2014 11:20:18 GMT -5 seanismorris said:

I agree.  The 27 to 1 is very positive.  And, approval is just about guaranteed at this point.  The 'concern' is about how many additional studies is the FDA going to require.  For example, the one for younger patients doesn't bother me because it expands the possible market for Afrezza.  But, requiring many more study's could hurt Mannkinds bottom line.  It's also possible that doctors could wait until any additional studies are completed before prescribing Afrezza.  The costs of the additional studies will hopefully be part of the partnership agreement.  Could this deter potential partners?  I don't think so, but you never know.  I'd like to see Mannkind become quickly profitable after releasing Afrezza so they can fund other Technosphere drug prospects.

FYI

I'm not a Bear (very much the opposite) but I think understanding the bear case for MNKD is important.

Here is the bear case as I understand it
1. MNKD is more than fully valued
2. Afrezza isn't as good as injected insulin at lowering A1c
3. Doctors didn't support Exubera for the treatment of Diabetes and Afrezza is just another inhaled insulin 
4. The Post approval studies are expensive and funding more studies will wipe out MNKD market value
5. Mannkind needs a partner to make Afrezza a success and they don't have one

As investors in MNKD we should all be able answer (reply intelligently) to these statements.  The reason MNKD sold off (in the FDA scare) in the day prior to Adcom, is because many investors didn't do their research...  

This thing about post approval studies being expensive misses the way medicine works (and that MDs feel comfortable about prescribing a drug). When someone say that post marketing studies will hurt the bottom line they are ill informed or feeding you spin. I could think of 4 or 5 100-200 million $ studies (each) and a few smaller 20-50 million $ studies that would take this drug from being a blockbuster to being as big or bigger then Lipitor ever was. Good return on investment? Yeah...

I certainly hope MNKD and Novartis (hoping we get a smart big pharma and not a 'has been' like a few I won't mention in case we get stuck with them) will spend the money and make this a mega block buster. As long as Mann is around I have no fear. Sadly he is not young... He knows what makes clinicians tick (and prescribe) before most of them do. He is a few steps ahead of most MDs and investors because he understands the science and pathology.

JPG