Approval/ Partnership.

[biotec]

If we get approved, How long after do we hear about a partnership? I think very soon after. AdCom,April 15th,Partnership An exciting month to be a MNKD long, Or a very bad one.

[nemzter]

Partnership is up in the air ... I'd say hopefully we get something by the Shareholders meeting in late May, but that's just anyone's guess.

They still have 3-6 months to ramp up production from the PDUFA date, so I guess hopefully within 6 months after approval

[StevieRay]

Mar 20, 2014 11:19:21 GMT -5 biotec said:

If we get approved, How long after do we hear about a partnership? I think very soon after. AdCom,April 15th,Partnership An exciting month to be a MNKD long, Or a very bad one.

My guess is potential partners are waiting for FDA approval/Label (Type 1 AND Type 2) before they are willing to commit. Once FDA approved for both types then I think we might actually see a full-fledged bidding war. There is a lot at stake here. If you are riding an RAA horse then you might not take too kindly to giving up a pretty good revenue stream over to a horse named Puff! Do you partner or do you buy? My guess again is it’s probably wiser to partner and see how it runs first. If it does take off like wildfire then buy them out. Sure it will cost more but at least you have mitigated the marketing risk. But, if you’re absolutely positive that Afrezza will be successful then it might be cheaper to offer something they just can’t refuse at this point in time.
I guess we’ll just have to wait and see. It is a very exciting time to be holding MannKind shares!

[babaoriley]

I have a suspicion that if we're approved, we get sold, rather than partnered. Or, perhaps MNKD can strike a deal like rak has suggested before, if I recall, that's sell Afrezza rights, maintain manufacturing and rest of company (technosphere remains with company).

[notamnkdmillionaire]

We will all find out very shortly.

[spiro]

There are a lot of wise people posting on this board. I would love for Rak to be right. It could be the best possible outcome for the longs willing to hold for a few years, after taking some profit. 

[rtccpa]

Mar 20, 2014 11:59:57 GMT -5 StevieRay said:

Mar 20, 2014 11:19:21 GMT -5 biotec said:

If we get approved, How long after do we hear about a partnership? I think very soon after. AdCom,April 15th,Partnership An exciting month to be a MNKD long, Or a very bad one.

My guess is potential partners are waiting for FDA approval/Label (Type 1 AND Type 2) before they are willing to commit. Once FDA approved for both types then I think we might actually see a full-fledged bidding war. There is a lot at stake here. If you are riding an RAA horse then you might not take too kindly to giving up a pretty good revenue stream over to a horse named Puff! Do you partner or do you buy? My guess again is it’s probably wiser to partner and see how it runs first. If it does take off like wildfire then buy them out. Sure it will cost more but at least you have mitigated the marketing risk. But, if you’re absolutely positive that Afrezza will be successful then it might be cheaper to offer something they just can’t refuse at this point in time.
I guess we’ll just have to wait and see. It is a very exciting time to be holding MannKind shares!

Since no one asked my opinion, I will give it. :-) First, we won't hear anything until post ADcom/ FDA approval. Then what? Not much. Al is simply asking WAY TOO much. I see some sort of partnership with a "domestic, relatively small" distributor. Al starts manufacturing on his own at a much reduced rate. No buy-out for a LONG TIME, after Afrezza has proven to be a winner.  Only then will we see our true reward. How do I know this? I don't! I just have this gut-feeling that's the way negotiations are going.

[alcc]

If you look at Al's history, he had no issues with selling his companies outright. So it's a matter of coming to agreement on valuation. If there is no agreement, then the best structure would be a royalty-based partnership with a takeout clause to be exercised when the market risk/value of Afrezza has been reasonably sorted out. In any event, I see our interests and Al's as 100% aligned. I, for one, will ride with Al.

[goyocafe]

Mar 20, 2014 15:32:00 GMT -5 rtccpa said:

Mar 20, 2014 11:59:57 GMT -5 StevieRay said:

My guess is potential partners are waiting for FDA approval/Label (Type 1 AND Type 2) before they are willing to commit. Once FDA approved for both types then I think we might actually see a full-fledged bidding war. There is a lot at stake here. If you are riding an RAA horse then you might not take too kindly to giving up a pretty good revenue stream over to a horse named Puff! Do you partner or do you buy? My guess again is it’s probably wiser to partner and see how it runs first. If it does take off like wildfire then buy them out. Sure it will cost more but at least you have mitigated the marketing risk. But, if you’re absolutely positive that Afrezza will be successful then it might be cheaper to offer something they just can’t refuse at this point in time.
I guess we’ll just have to wait and see. It is a very exciting time to be holding MannKind shares!

Since no one asked my opinion, I will give it. :-) First, we won't hear anything until post ADcom/ FDA approval. Then what? Not much. Al is simply asking WAY TOO much. I see some sort of partnership with a "domestic, relatively small" distributor. Al starts manufacturing on his own at a much reduced rate. No buy-out for a LONG TIME, after Afrezza has proven to be a winner.  Only then will we see our true reward. How do I know this? I don't! I just have this gut-feeling that's the way negotiations are going.

So Greenhill spent upwards of 7 months chasing their tail? I find it hard to believe they would continue to put resources (or ever start) if they understood Al's "rediculous" expectations. If they are still on the job, I doubt they're chasing windmills. JMHO

[harshal1981]

In my opinion, FDA will file for 3 month extension which is the pattern that I observe (1 month is unusual) when they AdCom close to PDUFA and on top of it, 15 days are not enough for FDA to finish plant inspection. In general plant inspections are done only after FDA has made up their mind. And it requires a week to audit and another two-three weeks for internal processing before NOC is issued. I am sure we all can agree than FDA will not make up their mind before AdCom and hence no plant inspection. I do believe that if FDA wants, they can finish label negotiations in two weeks but I don't think MNKD is in their high priority list.

That being said, until June/July, we better jack up our endurance power as I do believe that AdCom will have positive outcome but there will be couple of votes against it and that will for sure give short bag holders enough ammo to keep firing until extended PDUFA. (Btw, FDA can and does reject drugs even after AdCom yes vote and vise a versa. Not that I believe this product is going to be rejected. But extension of PDUFA and couple of Nay votes at AdCom will be enough to introduce nervousness and drive down price to 5-6 again).

After PDUFA I think, we will have to wait couple of more months. I don't believe we are hearing any thing before the label is finalized. Depending upon how much the scope is broadening with Type 2 diabetics and the therapy designation, the partnership or buyout pricing will vary drastically. And hence, there are chances that the negotiations can drag for at least a month or so. Remember that Al is not an easy to break and big pharma will try their best.

At best , we can expect to hear things by August End / Sep Mid. If you guys are really playing with options, my thinking is November is the earliest safe bet.

[mrhaigs]

I totally disagree with the 3 month. This is not a normal NDA. The FDA has been dealing with afrezza data for years. They will not need 3 months after an adcom. Well know approval or rejection by May 1.

[ezrasfund]

Al Mann expects this to be one of the best selling drugs of all time. Even after FDA approval there will be no way to know if Afrezza, technosphere, and all of the related products will reach their full potential. This gap between today's reality and tomorrow's promise is why there will be a partnership and not a sale. As they negotiate, every insistence by potential partners that the drug might not be a blockbuster can be countered with an offer to take less money upfront and more of the disputed revenue stream. This is one reason that Al continues to raise funds, IMO.

As to why the deal has not already been consummated; again, Al is not willing to sell at a discount because of future uncertainty. He has more information than anyone; plenty of expertise; and, unfortunately, plenty of bias, so he is willing to wait until the uncertainty is resolved to get his full price, and give competitors as much time as they need to bid. After a successful AdCom and approval, this a deal will be much easier to sell to a big pharma BOD. Without approval there is really no deal to be made.

[brentie]

Harshal, I think that there will probably be a delay too but I don't have a clue how long it will be. However,I don't think it will be caused by the plant inspection. They inspected the plant once before so that should make things easier and last time they had the inspection completed months before PDUFA. This is from the October 29, 2010 earnings call, two months before the December 29 PDUFA date.

Jon Lecroy - Hapoalim Securities

Okay. And then have all the pre-approval inspections for the plans in the U.S., international is all that finished at this point with the FDA?

Alfred Mann - Chairman and CEO

Well, all of that was completed. Except that, of course, now we have this new machine, which they may or may not want to evaluate.

seekingalpha.com/article/233332-mannkind-ceo-discusses-q3-2010-results-earnings-call-transcript?find=inspection&all=false

[StevieRay]

Based on how closely the FDA collaborated on the 2 most recent studies and the results of these studies and that this is their 3rd time up, I don’t anticipate any more delays what so ever. Call me naive but I truly believe we will be FDA approved on April 15th. In the unlikely event that there is a delay I expect it to be very short. They’ve been at this for a very very long time now and I just don’t see any reason at this point in time for anymore further delays. I’m not an options player so it really makes no difference to me but I guess if you’re attempting to time the market then it matters.

[spiro]

My bet is with Stevieray. But I will be even more naive and say that I wouldn't be surprised if the AdCom votes overwhelming in favor of Afrezza, the FDA approves Afrezza even before April 15. Lately, the FDA seems to be meeting there deadlines.