andy.strojny, yes, it does appear often in the FDA document that AFREZZA will be approved with appropriate labeling recommendations. I certainly think Afrezza will be approved for type I and type II diabetics. The negative comments from people who are posting both positive and negative articles and ymb posts give the impression that something about Afrezza that is not perfect will be rejected. That is just not the case.
bergstromrobert138, if you consult a daily chart of MNKD, you will see technically MNKD is in a compressed triangle pattern, aka wedge, from August and November of 2013 to today. These things normally act like coiled springs when a decisive up or down price move is finally made. Today on the chart I drew for myself months ago, the top of the triangle is about 6.7, and the bottom of the triangle is about 5.4. I expect more bouncing around of the MNKD stock price within this narrowing triangle right up to the Advisory Committee meeting and then even up to the PDUFA decision. Once a decision is made, AdCom and/or PDUFA, I expect the price to zip much higher or much lower suddenly and decisively. That is what would be expected.
You mentioned how many shares you own, and I own considerably more than you named. This volatility does not bother me, because I see plenty of stocks that get into these compressed triangles (or wedges). This MNDK triangle trend is neither rising nor falling. That is even more obvious on a weekly chart. We are just waiting on a couple of binary events, and you can expect volatility higher and lower until those events happen. My expectation is for a price rise much higher, because I believe we will see approval of Afrezza. In the interim I expect volatility. These weekly options are a particular reason I think we see even more volatility.
radgray68, anyone who bought MNKD since fairly early in 2011 continuously until about mid 2013 had a profit after the AdCom. That was a lot of volume of shares with memories of pain. A lot of those likely just did not want to see all those years of holding evaporate (sometimes again), and they sold. Sure a lot of them put in stops that got run. Sure a lot of the shorts covered and reshorted. So it is no wonder the action since the AdCom. Most if not all those volatility factors are gone or greatly attenuated. With decreasing volatility traders are going to move on -- eventually. The shorts know they likely don't have a lot of time left to figure out what they are going to do. Tick Tock.
If you do a search of Seeking Alpha Needs to Take Stock of its Policies, you will find an interesting article on the online barrons website that details some serious problems with SA articles and authors. You can read the entire article for free without giving any info to Barron's.
williamszxz, I see all of those after hours trades. It was almost no volume, and some traded at 6.93. The bid/ask was at 6.83/6.88 for what looked like an hour. Then a few meaningless trades trickled in toward the end. You might want to upgrade your broker so you can watch what is going on AH instead of looking at a Yahoo summary page.
Fox Business Network has Charles Payne who appears to follow MNKD closely. On the day in August 2013 that MNKD announced phase III results news for Afrezza, Payne interviewed Al Mann on his program on Fox Business. There may be something to CNBC's antimagnetic attraction for MNKD, because Cramer via his hatchet man, Feuerstein, has nothing good to say about MNKD, yet. Cramer will be putting a Post It note on his forehead later this Spring to explain to everyone why he got MNKD so wrong.
It would be quite a surprise if Afrezzauser is not there to present his experience in the recent Phase III trials of Afrezza. He has a lot of personal data about Afrezza he has experienced and presented to us on this board, and I am sure the AdCom panel will be very receptive to hear. I am sure Afrezzauser will also be very open to lots of questions from the AdCom panel.
pfg_01, just a point of order. Afrezza is not an insulin analog. Afrezza delivers to the blood stream monomer insulin just as the human pancreas delivers monomer insulin to the blood stream. It is real insulin instead of an insulin analog. I do not understand the sentence containing "older style human insulins." I am not aware of a human insulin other than real insulin from a pancreas, or perhaps hexamer insulin that can be injected and slowly dissolves in the blood stream to release some difficult to control amount of monomer insulin over a long time period.
pfg_01, it appears to me your 2nd and 3rd paragraph information completely covers, explains, and solves the puzzle the MNKD skeptics constructed. It is good reasoning of how MNKD can present new data at the conference in June while not having to release the data at the April AdCom meeting.
ericfenar, if you were in any of the Afrezza trials, you should present what life was like on other diabetes drugs compared to when you were using Afrezza. Present as many data comparisons as you experienced. If you were not in the trials, you certainly have talked to others who were in the trials. You can talk about your blood sugar control issues and how your discussions with Afrezza trial people would help your specific diabetes problems. I have not read your twitter feed, but I did notice you had some comment to Lee Iacocca's feed. Has he commented about Afrezza to some forum? It appears he does not tweet.
frankcastle313, no, Adam Feuer does not understand what he is hearing. That is why it is hard for him to follow.
Why would anyone pay attention to David Kliff? In the article he says diabetics have enough medicines to combat the disease now -- if they just took responsibility for their own care. This guy is a tool, and I think he is going to be wrong this time. He does not want any new insulin methods for diabetics. Clearly he is nuts.
I think the FDA people are going to get a lot more incoming flack after lunch coming from the panel.
jhnnylikes, until good education about Afrezza's mechanism and workings in the body are well understood by primary care physicians, endocrinologists will Need to be involved in type 1 and type 2 patient readiness. Sharp PCPs will get educated & involved to help their diabetic patients, but other PCPs will need to get an endocrinologist to lead the way for them. Primary care physicians are frayed at both ends these days, and need drugs that are simple to prescribe and use. I think PCPs will need plenty of education and sitting with some endo doctors to get it right for their patients, or they can send diabetics to endos.
harshal1981, it is hard to imagine you do not see what you outlined as fraudulent activity in several ways. Al could not do all your hocus pocus outline proposes without getting himself and the company sued for all kinds of fraudulent means. It appears you just want to instill some type of fear in people who might be ignorant of securities laws against the schemes you proposed.
pfg_01, I was playing no word game. I simply meant the insulin that Afrezza finally delivers to the blood stream is the monomer insulin of the same IUPAC insulin formula that a human pancreas delivers to the blood stream. To me when an insulin analog gets into the blood stream, if the active ingredient insulin does not have the identical IUPAC formula as pancreatic insulin, it is not real insulin or human insulin -- and it behaves differently in the body too. (Of course this is the problem Al Mann recognized and has solved.)
I will go along with you and call Afrezza an insulin analog in a strict definition, but upon dissolving Afrezza delivers in a strict definition real insulin to the blood stream that behaves exactly like insulin from a human pancreas. It should, because it is the identical IUPAC chemical formula as human pancreatic insulin.
afrezzauser, I have a lot of MNKD, and I am concerned. That FDA collection of panelists, I thought, was either incompetent in its fundamental characterization/understanding of diabetes and the diabetes data, was playing dumb, or was corrupted. They were an embarrassment to themselves and to medical research.
cedafuntennis, yes, the replies to the question about trial design were weak coming from the FDA people.
sugarman005, I have read many of your posts in the past several months. It appears to me you work in some medical field, but my memory is not clear on this. Am I correct? I do not need details.