I must say I find this lack of accumulation absolutely baffling. MNKD has a product which will almost certainly sig. increase compliance - thus likely save society vast sums of money over the long-haul, has never missed an endpoint, has proven safer and superior (to varying degrees depending on the metric and the trial) to anything currently available, and which multiple professional surveys have indicated will capture an absolute minimum of 20% of a roughly $20 billion prandial insulin market (with insulin use apparently increasing globally 10%-plus annually - it will likely be a $20 billion global market by 2016 anyway, if it isn't already). That 20% minimum capture equates, or will equate shortly, to approximately a $4 billion revenue stream by 2016, and I think a 40% capture rate is much more likely by 2017, maybe 2018(?). We are talking a good chance at a huge multi-blockbuster product which, with proper aggressive marketing, could easily send MNKD shares to the $45/$55 range, and that is with a partner and only say a 25% market capture! Then you might get a buyout at $70 as well.
I can understand Deerfield attempting to keep the share price as low as possible, I can understand the MMs and possibly hired gun hedgies doing Big Pharma's bidding - but what explains the lack of significantly heavy accumulation by other players? Is the game so rigged now, that there really is only just various manifestations of the same controlling power? One could begin to get the idea that there is material non-public information out there, or that WS's Big Money is all pretty much coordinated something akin to organized crime. Sure, MNKD may need to raise money, probably not until Q1, but even if there was a minor dilution coming within weeks - in spite of management's apparent indications - so what? Something just doesn't add up here. Since when does WS's Big Money just sit out such a favorable risk/reward scenario?
Yep, a couple of good comments refuting that short clown have been left. Those news notices rarely generate any comments, so this is a good thing.
An 'early' approval would be nice, but considering the shear volume of the NDA submission, I wouldn't be surprised to see things go the other way with FDA requiring more time for the review. This is possibility is why I have avoided the May options.
"Just to let you know - in the recent Afrezza trials, it has been indicated that roughly half, or a bit more, of the total hypoglycemic (low blood sugar) events were all reported from just one trial participant!"
"One could easily speculate that this individual was NOT following protocol - those with a conspiratorial bent could even conjecture that this individual was intentionally trying to influence the trial results in a negative way - hmmmmm? Just food for thought, and something readers should be aware of."
"BTW, a regular poster on the Yahoo MNKD message boards by the name of 'afrezzauser' has actually participated in the trials, and yes this 'fact' has been verified - he reports stunning results regarding the effectiveness of Afrezza use in controlling his blood glucose levels and eliminating hypoglycemic episodes; I believe he actually has stated that except for the trial protocol, he feels he could have achieved even better results than he achieved during the trial. So apparently, if one throws out the reported hypoglycemic events reported by this one other trial participant, then Afrezza delivered an absolute homerun as regards overall efficacy/safety - the reduction in low blood sugar episodes for everyone else was much more impressive than the trial stats might at first indicate. *I believe, from memory, this information was alluded to in a post-trial interview which Al Mann (CEO of MNKD) participated in - I didn't actually see this interview but have read of it."
Friday's are a joke, have been for quite awhile as everyone leaves early or don't even show up. When the markets are so rigged as they have become over the last few years, fewer and fewer individuals participate, and the power becomes ever more concentrated. We can thank Bernanke, Obama, and the big WS players like GS, JPM, BAC, etc., and of course the HFTrading shops plus the exchanges who have sold their souls for a bit of phony volume. I only pop into the markets briefly on Friday's anymore, just happened to see your post.
Our day should be coming with MNKD, at least by April, unless the fix is already in with FDA. We have some evidence of increased inst. accumulation, but on a scale far too small to break the hold which shorty and the MMs have on this stock. It seems most are waiting to at least see if the FDA will be accepting the NDA as is. It would sure be nice to hear something concrete from that country which supposedly was considering a quicker approval than the FDA. With so much evidence for superior efficacy and safety, it just is astounding to me that other countries haven't already, even a couple of years ago, given the green light to secure Afrezza for their populations.
Such an outstanding post. We have been lucky to have an actual user from the trials posting here.
You do understand that the shorts, the pros, are already well hedged with options and are rarely caught off-guard by a partnership announcement - WS being a place not known for keeping secrets well and all.
Good info, but I think you are on the conservative side with REGN's P/S numbers, maybe intentionally, as they come out closer to 17 than 15. No matter, cause it is much safer to use the conservative numbers which CELG has. On the other hand though, at least for the first few years MannKind's profits and growth will more closely align with REGN's, so maybe the 15 multiple is actually the more realistic metric. Wow!!! Let's just say that ballpark, for $4 billion in revenue and that figure likely to continue growing for years, Al would be absolutely nuts to sell MNKD for anywhere near G.Rho's figure of around $30. In 4 years, if our market capture assumptions are close at 20% plus, then MNKD's share price could easily exceed the $100 mark. And I am assuming we have at least 450 million shares by then.
Congratulations, you likely just earned a place on the next 'no-fly' list, an almost certain audit from the nice people at the IRS, and a reserved spot in the nearest FEMA camp when the time comes.
Have to agree with other poster. No realistic reason to withhold positive trial results for extended period of time - that is just absurd. You get the news out of a win - then you can #$%$ around for months 'fine-tuning' the specific particulars in the best light or delay to present at a conference. Beginning to suspect there is bad news coming.
Even though I would love a load the boat opportunity around that $1.50 4-year support, just can't stay out any longer. In this toppy low volume market, shorts have their way with unusual ease, but at some point, likely not too distant, it will suddenly be pedal to the metal in reverse as they ride her back up. Of course, with such depressed s/p, there is always the potential of a left field acquisition offer surfacing, or just a bigger badder hedgie group recognizing a no-brainer opportunity to squeeze these short puppies for a handsome 40% easy money gain.
Nice to get some overdue coverage.
When you take out smokers and those with COPD, probably still leaves 70% of diabetics, and even a 10% capture rate gets us to blockbuster status. Not hard to imagine MNKD pulling down over $60 in a buyout in maybe 4 years.
Great post rich, couldn't agree more. My guess is it takes somewhere around 3 years, and by then the prandial insulin market should be at $20 billion if it isn't already. From what I have read, diabetes is increasing at from 8 to 12 percent each year, depending on the country.
Unfortunately, this doesn't allow quite the strong hand for MNKD going into BP negotiations we had hoped for them/us. I am growing concerned with the short interest increase of late as it seems to me to be classic pattern where the shorts are increasingly confident that Al will be forced into another capital raise. I have only little doubt that they have their inside sources with either Deerfield or Green Hill (or is it Greenhill), anyway, just seems the shorts are too confident at this point. My options are almost exclusively 2015 just in case.
Now THAT figure of nearly 100% makes more sense to me. Honestly, some of these estimates of 5 and 10 percent capture have always seemed absolutely absurd to me. I can see 50% switching over within 2 years. There are always going to be those diabetics which smoke or with existing pulmonary disease, those who just fear inhaling anything into their lungs, and those who are just comfortable with injections since they have used them for so many years, but that still has to leave at least 50% who will gladly switch.
Hope nobody got shaken out. MNKD is such a no-brainer down here at $5
Even if one believes that Afrezza only captures a 5% share of the prandial market, that still makes it a $15 stock at that point. My guess is that 1 in 20 will sign up within 8 weeks of commercial availability as long as the FDA grants an unencumbered label and insurance has kicked in.