Dr.Margaret Hamburg, FDA Commissioner

[cocokitty]

Hello Everyone,

I have been reading this board, agora com boards and yahoo boards for several years now.  I find most of the information on this board to be of most value.  I am long mnkd and hold a substantial amount of shares.  Is anyone nervous about Margaret Hamburg.  Her husbands company has a large interest in Eli Lilly and Novo.  I was reading yahoo today and came across someone discussing this very issue that if mnkd is approved it can hurt her husbands hedge fund.  Is Al Mann and the FDA aware of this situation.  Her husband holds a substantial interest in Eli Lilly and Novo.  Anybody know more information on this subject.  Check out the yahoo message boards to read the post by paulanthony00766.

Thanks
Coco

[spiro]

That would be NO !

[liane]

spiro,

No - you're not worried; or no - MNKD does not know Peter Brown has a large interest in Novo and Lilly?

[babaoriley]

He's not worried, Liane, and MNKD is most certainly aware of Hamburg's husband.

[spiro]

Sorry,  no  and yes, the shorts need something else to talk about. 

[mnkdfan]

Hi all,

I vaguely remember hearing Matt made a reference at one of his earlier conference that the FDA has a new NDA director (I think Mary Parker or something got promoted) in place and that MNKD is unsure if this personnel change may have an impact on the Adcom decision. Do any of you recall that comment from Matt.

It would seem to be a prudent thing to do with a novel new drug like Afrezza and the new director not having the history with MNKD that an Adcom is convened. Once I got over and accepted my (I believe temporary) MNKD drop in stock value, I realize that the adcom is actually a needed component for FDA approval so it is a good thing down the road for an FDA approval,in my opinion.

[brentie]

mnkdfan, here you go...

Josh Schimmer - Piper Jaffray
Are you expecting an FDA advisory committee review and if so what might topics of that review be?

Hakan S. Edstrom

We don’t know at this point in time. Probably earliest we would know would be in conjunction with the 74-day letter. We know that the application has been accepted by the FDA and the 74-day letter is somewhere in between the 28 and the 30th of this month. So again, it has not been addressed by the FDA. There has been a change in the leadership from Mary Parks to Dr. Guettier, whether that will change the projection for a potential advisory board or not, we don’t know at this point in time.
Josh Schimmer - Piper Jaffray
When does that leadership change?

Hakan S. Edstrom

Mary Parks was promoted probably back in the August-September timeframe. I don’t remember exactly. We know that she is still somewhat enrolled with application but we know that the leadership role has been taken over.

seekingalpha.com/article/1877451-mannkinds-management-presents-at-the-piper-jaffray-25th-annual-healthcare-conference-transcript?find=advisory&all=false

[jpg]

I for one certainly think the addition of an open and transparent process like an adcom is not a bad thing. Cards are laid on the table and an open and above board discussion follows.

I am tired of the years of delays and want thjs approval 'done and over with' but obviously it doesn't work that way... From everything I know of Afrezza (and it is true we only have a fraction of the information Deerfield invested millions with) an adcom is a good thing.

The timing of the adcom request (not in the 74 day letter) I will assume is intended to be seen as a positive or at least not a scary thing. The timing of the adcom so close to the 15th of April leaves me slightly puzzled. It could mean the FDA will approve and needs guidance on label and/or a rubber stamp (as some suggest). It could also mean the FDA is dysfunctional and doesn't care about the realities of biotech and will disregard their own rules and promise of better timeframes. I tend to favor the first reasoning. I see a 'new and improved FDA' aiming for efficiency and transparency.

[mnkdfan]

Thank you Brentie!!!

[ezrasfund]

It's hard to believe that anyone who has been following MNKD for several years hasn't heard too much about "Hamburg and Brown". There have been countless YMB threads with thousands of posts on the subject in the last "several years". Now can we please discuss up pulmonary safety, falsified Russian trial data, and other issues of real concern?

[chmith27]

IOW coco, take a hike.  nobody's buying your act.

[babaoriley]

Now, that was quite a hiatus! But back with a vengeance! Welcome, doc!

[oracle]

coco, last word I can recall is that he's now long on MNKD with 2m shares.

[babaoriley]

Nice one, oracle!!

[cocokitty]

I am very disappointed in this board. I am pretty new to this kind of investing. I do a lot of reading and came upon YMB and agoracom website and now I am here since everyone moved over here. I find all of you very inspiring and at the same time am a bit disappointed. As a new comer I thought I could write something in and get a decent response but all I got was negativity in regards to my inquiry about Margaret's husband hedge fund and it's association with mnkd. For your information I am not short. I am a nurse that see the importance of this inhaled insulin and I have several relatives that could benefit greatly from this new technology. Dont't worry, I will never write on this board again. I don't need your condescending remarks especially from spiro and baba and chmith27. I will continue to read to gain valuable information but will never write another post. I was looking forward to meeting some of you at the shareholders meeting but that remains to be seen. Coco