Can someone tell me how is the attempt to get partnership this time differ from the last time? Why didn't we get partnership last time? Is it because Mannkind didn't provide sufficient data whereas more detail data this time?
I think it is much different this time. There is so much at stake regarding the commercialization of the product for it to be effectively introduced and marketed - and there is no time to waste. Most appear to believe a partnership is the best way to go. I do too because it will allow the "professionals" to handle the marketing and distribution of the product. With respect to driving a hard bargain, the retention of Greenhill is a concession to professionalism as well. Greenhill will serve as the necessary buffer to solicit and cultivate and ultimately marshal the process of obtaining the best proposals available at this time - whatever they are. this will benefit the shareholders of MNKD - and especially Al Mann, because he will know the score and not just cowboy the future of the product just because he can. I am not buying or holding stock on the basis of going it alone from this point forward. The only logical alternative to partnership is an outright sale at the appropriate moment - if there is a willing buyer....and Greenhill's process will likely determine that irrespective of whether it is the assignment they have been retained for.
agree with faried to a point, but I think the situation is complicated by the control of Mannkind being absolute and in very strong hands. Mannkind reminds me alot of imclone, except this time the founder is more powerful and has the wealth to go it alone. All is like the founder and the Carl Ikhan activist all in one. Therefore big pharma cannot try to leverage a favorable deal prior to approval. A smaller, less risky deal, could be reached, but that is probably not what the Pfizers or Sanofis want either. They want to be able to map out future cash flows with some certainty and purchase the company accordingly.
nannaki, there was no partnership the last time because there were red flags in the NDA application - the device used for the NDA filing (Gen2) was different from the device used for clinical trials (Medtone). I remember Al mentioning in a conf call that the potential partner attended a meeting with the FDA to discuss the NDA application .The big pharma opted to wait for the FDA decision. Of course MNKD resisted having to perform 2 clinical trials as this would set them back at least 2 years. The FDA issued a CRL asking for 2 clinical trials. This time around, the new 2 clinical trials completed address all of the FDA's issues and there are no more open issues or red flags. No reason why partnership will not happen now.
Just want to bring this topic back again because eveyone would like to see a realistic picture at thus point before FDA.
From finance perspective, I think MNKD can go alone for now, but what if there's a So it appears MNKD has a potential partner review the NDA application before delay in FDA approval just like last time , and if it prolong for more than a year, would partnership ASAP be more reasonable. My guess our partner is probably reviewing with MNKD as we speak. If so, we should hear something by October. Any educated guess.
Thanks for your input bbarra, for some reason I felt Mannkind trying to hype their pps for a reason. I understand the pps being hit hard, but Mannkind filing the 8k to make it clear seem desperate move. I know we are speculating at this point but I'm still puzzling of their intention. Just a thought.
Despite what alot of pumper on this forum are telling you, big pharma is not going to offer mannkind a multibillion dollar deal prior FDA approval. Dont believe the pumpers on this forum, big pharm companies are not getting in line to fight over powder insulin. Although there is a market for it, the FDA will put restrictions as to who can use it and what kind of pulmonary test need to be perfomed bi-yearly. As a result, its sales will be questionable. Thus mannkind is going to have to market the product itself and show big pharma what numbers they can pull. Obviously, if they do well, big pharma will make an offer. Why risk billions like Pfizer, when you can eliminate the risk by letting mnkd take all the risks.
Inhaled insulin has already been approved, Exhubera. It was never taken off the market by the FDA. It was pulled by the manufacturing partner due to lagging sales only. If there were serious concerns about the use inhaled insulin the FDA would have required such constraints on Exhubera which they did not. Afrezzaq now has been tested and used on some 7000 patients without any evidence of significant or non reversible pulonary implications. What you are suggesting is that the FDA move the goal posts. You are suggesting they treat both inhalable products differently.
I agreed with you. Just like last time when Mannkind keep alluding about getting a partnership and nothing has been accomplished. Just like Motley article that Mannkind could be trying to hype their company to increase pps so they can start selling share. Now the real truth will come out before year end if they are going to partner or not because the have to pay off convertible debt. Will they dilute more share if no partner?