FDA Approval & Partnership Questions

[slushy]

Hey group,

I know we're all basking in the afterglow of the AdCom, but I want to make sure we don't get surprised coming into Approval and beyond. I was hoping some of the more knowledgeable members would be able to help answer or speculate on some of the questions I've been kicking around the past 24 hours:

1) For the times the FDA does not go with the AdCom (I believe it's 86/14 split), how often were the rejections based on weak AdComs? Basically, how many were rejected that had results similar to ours (basically a clean sweep)?
2) How likely is it the FDA uses their extension to push their approval beyond 4/15?
3) What are the primary pitfalls going into FDA approval? What are the primary labeling concerns? Is there anything they can do that would hurt us even if they approve both Type 1 and 2?
4) Who are the front runners for a partnership? How long until we get that partnership post FDA approval? What are the chances we get acquired instead of a partnership?

I know a lot of these questions will require a lot of speculation, but these are the main areas that I see being able to push the PPS hard one way or the other. Please add any primary concerns you think I'm overlooking.
Hope everyone celebrated at least a little bit last night, we weathered a very rough storm yesterday.

[mnkdwillwin]

Good ?'s hope to see them answered myself. I couldn't sleep a wink last night. Just dreaming of win and what it means for so many. Nice weather here.

[liane]

I won't hazard a guess to most of your questions. I will say this re #2. Until yesterday, I thought a delay (1-3 mo) was likely. But seeing how solid the vote was, and the outstanding public open forum, I would wager on no delay at this point. Just my .02.

[mdcenter61]

Apr 2, 2014 11:43:41 GMT -5 slushy said:

Hey group,

I know we're all basking in the afterglow of the AdCom, but I want to make sure we don't get surprised coming into Approval and beyond. I was hoping some of the more knowledgeable members would be able to help answer or speculate on some of the questions I've been kicking around the past 24 hours:

1) For the times the FDA does not go with the AdCom (I believe it's 86/14 split), how often were the rejections based on weak AdComs? Basically, how many were rejected that had results similar to ours (basically a clean sweep)?
2) How likely is it the FDA uses their extension to push their approval beyond 4/15?
3) What are the primary pitfalls going into FDA approval? What are the primary labeling concerns? Is there anything they can do that would hurt us even if they approve both Type 1 and 2?
4) Who are the front runners for a partnership? How long until we get that partnership post FDA approval? What are the chances we get acquired instead of a partnership?

I know a lot of these questions will require a lot of speculation, but these are the main areas that I see being able to push the PPS hard one way or the other. Please add any primary concerns you think I'm overlooking.
Hope everyone celebrated at least a little bit last night, we weathered a very rough storm yesterday.

Slushy - pretty good article on the Adcom percentages here:  seekingalpha.com/article/2122143-history-shows-mannkind-has-a-near-certain-chance-of-approval?isDirectRoadblock=false&uprof=45

Personally, imho FDA will probably hit us with a delay, maybe 30 days or so; but hopefully not.

I will defer to the medical professionals as to labeling etc.....

Mike

[krj00]

I don't understand all this talk of "potential delay".  Of all things, FDA does make a big deal about hitting Pdufa timeframes. Plus, any potential concerns are all longtime known and most certainly hashed out over the "years" of delay already.  I say FDA is ontime and promotes it as a feather in their cap.

[babaoriley]

Apr 2, 2014 11:47:55 GMT -5 liane said:

I won't hazard a guess to most of your questions. I will say this re #2. Until yesterday, I thought a delay (1-3 mo) was likely. But seeing how solid the vote was, and the outstanding public open forum, I would wager on no delay at this point. Just my .02.

I'll see your .02, so now we've got .04 saying that there will be little or no delay from 4/15 date.

[slushy]

Thank you for that md! I'm feeling pretty confident that we get the FDA approval, but I'm still nervous about the labeling and how that is going to come into play in regards to partnerships/marketing.

[mdcenter61]

Apr 2, 2014 13:01:57 GMT -5 krj00 said:

I don't understand all this talk of "potential delay".  Of all things, FDA does make a big deal about hitting Pdufa timeframes. Plus, any potential concerns are all longtime known and most certainly hashed out over the "years" of delay already.  I say FDA is ontime and promotes it as a feather in their cap.

I'll go with your thinking, krj, just a long-time jaded long who still thinks FDA got a little pantsed yesterday and will mess with us a little bit. Probably need to go put the Reynolds wrap on my head.

Mike

[biotec]

With FDA approval and a great partner, I can see us being in the high teens-20's

[nadathing]

My gut feeling was that Al knew what the results of the Adcom were going to be. Just a gut feeling. No back room deals were made, but he has worked closely with the FDA and they could see all the data before it hit Adcom. Many have speculated the Adcom was to address labeling issues. There is a chance this has all been decided and the Adcom was a formality to (again as others have speculated) get everything out in the open so there is no question in the public's mind that Afrezza is safe and effective. Is the decision already made and the game already decided. My instincts say yes.

[MnkdMainer (MM)]

I agree with Nada and Liane.  After the human cost of the past delay, and given the overwhelming public comment, I don't think the FDA wants to be responsible for any further delay, particularly when there was no new information that would justify a delay.

[spiro]

Ok guys, now that my optimism has been adequately recharged, I will try to convince everyone that everything is on track for a prompt FDA approval. It's not only that  the panel voted overwhelming for approval, but you must consider that most of them made strong statements about the need for more options being available for diabetics. Some of their arguments for approval were actually quite compassionate for AdCom members. For me, the most interesting and exciting part of yesterday's AdCom was the total lack of questioning regarding the technosphere delivery powder. It appears the entire committee basically endorsed technosphere without a challenge. The questions and concerns were clearly focused on Afrezza. It seems as if some of panel didn't know that Afrezza was an insulin. BTW panel, I am not sure some of you realize how difficult even injectable insulin can be in establishing proper dosing. It is my understanding, that if a doctor can convince a patient to start insulin, that most patients could require tweaking of their dosage. I think the FDA should understand that. Now back to technosphere. Is there any doubt that technosphere was the real winner yesterday? It is my opinion that the value of technosphere being used with other drugs may far exceed the value of Afrezza. Believe me here folks, BIG PHARMA knows this. MNKD will either get a partner soon after FDA approval or they will be acquired within month's. Think about it again, techosphere, inert, pain medication dissolves in lungs, active within 5 minutes, no liver toxicity and minimal side effects. Remember, a technosphere pain application or vaccination will not be a daily dosing for a lifetime. It will be used as needed after surgery, migraine or even possibly arthritis pain. Certainly the long term risk profile will be much lower than Afrezza. Because of my infatuation with technosphere, derived mostly from talking to Adriana Leone bay and Jonathan Goldman at the Drug Delivery Conference, along with yesterday's strong endorsement, I have begun accumulating shares again. It appears obvious that our road will continue to be challenging, but now the odds favor us much greater.

Spiro here

I may have to get more counseling from Babaoriley to control my resurgent confidence.

[notamnkdmillionaire]

Apr 2, 2014 18:25:46 GMT -5 spiro said:

Ok guys, now that my optimism has been adequately recharged, I will try to convince everyone that everything is on track for a prompt FDA approval. It's not only that  the panel voted overwhelming for approval, but you must consider that most of them made strong statements about the need for more options being available for diabetics. Some of their arguments for approval were actually quite compassionate for AdCom members. For me, the most interesting and exciting part of yesterday's AdCom was the total lack of questioning regarding the technosphere delivery powder. It appears the entire committee basically endorsed technosphere without a challenge. The questions and concerns were clearly focused on Afrezza. It seems as if some of panel didn't know that Afrezza was an insulin. BTW panel, I am not sure some of you realize how difficult even injectable insulin can be in establishing proper dosing. It is my understanding, that if a doctor can convince a patient to start insulin, that most patients could require tweaking of their dosage. I think the FDA should understand that. Now back to technosphere. Is there any doubt that technosphere was the real winner yesterday? It is my opinion that the value of technosphere being used with other drugs may far exceed the value of Afrezza. Believe me here folks, BIG PHARMA knows this. MNKD will either get a partner soon after FDA approval or they will be acquired within month's. Think about it again, techosphere, inert, pain medication dissolves in lungs, active within 5 minutes, no liver toxicity and minimal side effects. Remember, a technosphere pain application or vaccination will not be a daily dosing for a lifetime. It will be used as needed after surgery, migraine or even possibly arthritis pain. Certainly the long term risk profile will be much lower than Afrezza. Because of my infatuation with technosphere, derived mostly from talking to Adriana Leone bay and Jonathan Goldman at the Drug Delivery Conference, along with yesterday's strong endorsement, I have begun accumulating shares again. It appears obvious that our road will continue to be challenging, but now the odds favor us much greater.

Spiro here

I may have to get more counseling from Babaoriley to control my resurgent confidence.

SPot on Spiro. Techonosphere has always been the underlying star that goes severely unnoticed. Even the dipwad analysts keep ignoring it. I am hoping we'll be quite surprised about what has been going on behind the scenes once the FDA approves Afrezza and the training wheels comes off of MNKD.

[babaoriley]

"I may have to get more counseling from Babaoriley to control my resurgent confidence."

Don't worry, Spiro, I'll reach out to you tomorrow, tried today, but you were apparently burning up the phone lines!  Oh, you definitely need a dose of down from me!!