Funny thing is that with just a positive update regarding the Greenhill negotiations, assuming things have developed 'positively', Al could put such intense pressure on the shorts that I find it hard to believe they could hold on. Obviously we all know there are confidentiality agreements, but it does strike me that Matt could really light a fire under the short position while still parsing that fine line of legality. Of course there would have to be genuine progress. I think even a general statement would be helpful to us longs.
Apologies dereklinders, I probably missed your earlier posts re. this issue. No intent to mislead. I thought this was discussed awhile back and that it came from some interview that Al did after the two trials were completed. Maybe slobber can find one of the posts or pfg can direct us to that interview. It could have easily been severe hypos, but even if that is the case, and near 50% of those did come from just one individual, that definitely casts things in a bit different light. Apparently Al, at times, goes a bit overboard, so assuming he did make a statement along those lines, maybe in reality the figure will turn out to be closer to 40%?? Anyway, the point of my post was just that the venue will afford MNKD the opportunity to paint a more realistic picture about this specific (hypos) particular where we all feel Afrezza has distinct advantages, but where this specific trial may have been a bit disappointing vs what we were expecting.
Sentiment: Strong Buy
At least that was apparently what Al Mann revealed in an interview not all that long ago.
Yep, but don't forget exercise and supplements like cinnamon, bitter melon, etc.
It is also a possibility that the prime BP partner/acquirer has requested an AdCom for reasons not clear to us. You know as much as we love to badmouth the FDA, and they honestly deserve all the mud imo, it is possible that they wish to really stick it to the shorts and set up an absolutely positive AdCom. They, at the top, may greatly resent that their hand was forced last time around. Though if that was the case it does seem that MNKD would have been privy to the plan, and not been caught off-guard.
Will be very interesting to see if this person does in fact appear to be more and advocate than an adversary, maybe he introduces the potential for Afrezza to be utilized in the huge pre-diabetic arena.
Indeed a bit more transparency, even a press release reiteration of the positives by the company with update on partnership negotiations couldn't hurt and if worded appropriately it might really put the shorts in a bind. Of course an outright partnership announcement would serve even better, but that is looking highly unlikely until FDA has spoken.
There is just no way to know why we don't have a partnership. It could be as simple as Al thinks Afrezza could be one of the most successful pharma products ever, and Big Pharma outfits think it will just be a good product but not a mega-blockbuster, so they can't reach an agreement. I guess it is obvious that Al wanted more than the Big Boys were willing to pay, but that doesn't mean Al is being unreasonable. A solo launch usually is a very expensive proposition, but then my suspicion is that Afrezza will be a very easy sell, so it is possible Al has decided to go it alone, at least for the first 6 months or so. Besides the capital and marketing expertise, I worry most about not having the political muscle which a Big Pharmaceutical partner would bring to the table. I thought for sure, with that recent run towards $7, that the shorts were beginning to cover but it seems they have instead counter-attacked and have now dug in. It still is maybe a tad early, but I'm thinking they may now simply not cover going into AdCom.
Such absurdity. Somewhere, I thought I read that MMs churning millions of shares back and forth was frowned upon by the SEC.
I doubt in a market like this, they will have any trouble dropping us well below $6, IF they want to. Question is can they close us near the low. Personally, I think MNKD is a $30 stock before too long, so if the shorts drop us to $5.50 or even $5.00 I don't care.
Wouldn't be surprised if the short position is now approaching 61 million shares. So patently humorous as these shares all have to bought back.
Sentiment: Strong Buy
I must admit that the lack of volume after what is clearly another, though some could argue an incremental, positive development is simply perplexing. ZTE is being squeezed into a position where a settlement seems ever more prudent for them - yet VRNG just can't seem to generate any serious interest. I could understand if Google or a major short (likely both in the same) was able to suppress the sh/p as they have almost forever - but how do you explain the lack of interest when they keep racking up the wins? Just puzzling to me. Shorty doesn't seem the least bit interested in a serious bear-raid to knock the sh/p down hard below $4.
The AdCom group members are appointed by FDA and they also provide a Chairman who I believe is usually or always an FDA employee. At times they will also have one or more non-voting members, possibly as advocates. At times they also allow for others, usually advocates for approval, to come in - say like diabetics who have been on the trials and wish to express first-hand experiences and opinions to the AdCom group. At times the company up for review will facilitate/coordinate the appearance of advocacy groups or influential individuals to appear before the AdCom.
The company up for approval is given time to 'make their best case' for approval and is subject to questioning by group members, after which the FDA Chairman will usually present a few specific questions to the AdCom to be debated and voted on i.e., is there sufficient evidence to indicate that Afrezza has been demonstrated reasonably safe?; or, has sufficient evidence been presented to indicate that Afrezza is as effective or superior to existing medications? With great luck they might even throw in a wildcard like 'does the body of evidence indicate that Afrezza use would be of sig. benefit in the pre-diabetic population which hitherto has been utilizing only oral medications'? The 'endpoint' or purpose of the meeting is to answer by vote the specific questions put before the group by the FDA, and possibly provide clarity for such things as label issues - restrictions, warnings, periodic testing requirements, follow-up studies, etc.
A link to an article by William Faloon published in Life Extension magazine’s May/June 2012 issue. Basically saying the current testing likely misses a sig. percentage of those who suffer from serious post prandial insulin spikes lasting say a couple of hours, but whose bodies manage to get things under control after awhile - thus they don't register on a routine 8 to 12 hour fasting glucose test; or maybe they register as pre-diabetic, but the damage to one's health over years of this is very serious. With luck we can eventually have Afrezza approved, and receive insurance coverage, for the huge per-diabetic population.
Agree totally. Even conservatively, and with a BP partner to split up the profits, we should be looking at a 10 bagger. The only thing which gives the shorts such a tailwind and why MNKD isn't at $12 right now is the FDA's reputation.
These of course are rough averages, and the cost to any specific dev. biotech varies greatly if a BP partner is on board. Per-patient figures are from a July 22nd 2013 Business Wire article and actually were specific to oncology trials, and the 90% figure is from an April 2012 article out of the Manhattan Institute for Policy Research titled "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials" by Avik S.A. Roy
* "Overall, Phase III trials now represent about 40 percent of pharmaceutical companies’ R&D expenditures. But this often-cited statistic actually understates the gravity of the burden. This is because overall R&D expenditures include all pharmaceutical candidates that a company tests—including hundreds that never reach the Phase III trial stage. When we confined our analysis to those drugs that actually get approved, we found that Phase III clinical trials typically represent 90 percent or more of the cost of developing an individual drug all the way from laboratory to pharmacy."
SAN FRANCISCO (AP) -- A divided federal appeals court has struck down California's concealed weapons rules, saying they violate the Second Amendment right to bear arms.
The 9th U.S. Circuit Court of Appeals said Thursday that California is wrong to require applicants to show good cause to receive a permit to carry a concealed weapon. The court ruled that all law-abiding citizens are entitled to carry concealed weapons outside the home for self-defense purposes.
I think you are right. Makes sense that they would hold it under that $ 5.00 mark if they could. Hope none of our long-term longs got shaken out by these scoundrels.