For the record I do not have a position nor do I plan on taking a position in Mannkind before an FDA decisionis made. Those that want to discredit me for saying that I have another motive well there you go.
1. The trial results show that Afrezza is statistically non-inferior to Novolog when efficacy is considered alone. In addition, Afrezza has been associated with significantly fewer hypoglycemic events than the comparators, and that is an important safety issue. So, Afrezza is as good at lowering HbA1c as Novolog, but it causes fewer hypoglycemic events. And as a result, Al correctly stated that his drug is clinically superior – based on safety and efficacy.
2. The writer took the reference to the 4 year-olds out of context. What Al was talking about at the time children were mentioned was the ability to manipulate the device – it’s simple and easy to use.
3. The “weight advantage” is a difficult issue to consider seriously for me. I’ve said little about it in my reports because weight gain/loss has been relatively small in my opinion (including 3.5 pounds in a 6-month trial). Personally, I can gain or lose 3.5 pounds in a day, based on my level of activity and the amount of food I consume prior to weighing myself. I don’t know why Al has brought this up so much except it is an issue for some diabetics who feel that taking insulin makes them gain weight. The reports of small weight gains make me wonder if the individuals’ intake of calories increased once they started to feel “protected” by taking insulin.
AU: "Afrezza has been associated with significantly fewer hypoglycemic events than the comparators"
which comparators are you looking at? the only trial where they did better was 171. it was twice as bad in 175. it was better in 117. i'll let others decide if 6 vs 8 is "significant." and in 009 the numbers were pretty similar across both arms.
So where are all these comparatorS where Afrezza significantly outperformed??
You can't compare results from 171 and 175 with each other as they both deal with two unique types of diabetes patients, each using different insulin in a different way.
There were a great deal of positives in 171.
175 did achieve lower A1c levels than comparator and achieved statistical superiority, even if that means more hypos.
Because Afrezza changes the way diabetes can be treated, it has had a very hard time surpassing the current standards of successful control blood sugar.
So Alsneeza is the best thing ever and you have no position? LMFAO. Right. You've lost all credibility after that. The insiders seem to agree with you. Best thing ever and they're selling $Millions worth of shares.
Afrezzuser, i summed it all up under oppie's(opc) post....my thoughts also. Although, i think after adcom would be a good time to enter into a small position at least...depends on the vote. a completly neg vote could make mnkd a really good buy for a position and the same for a positive vote, but i will wait till the dusts settle a few days after the adcom anyway. i'm heavy in kerx and chtp. i'll stay heavy in kerx and use some of those shares to buy mnkd after the 4/15 approval. chtp i will keep a small position after run, because i believe they will be bought out after approval. use those funds also for mnkd if needed. it's all good. i wouldn't be surprised if the fda pushes the pdufa date out from 4/15....extention,again. just because the adcom could raise issues the fda hasn't contemplated......making this whole thing too risky for me for now. JMHO
I am buying chtp tuesday. Looks like 4.50 is strong support and base for the pps to rise from. After what the pps did on thursday after the adcom vote u can see how mnkd will react to a positive adcom.
Nobody knows if the tentative date for April 1 will be the actual date for the adcom. It could be sooner or later.
While there is always the possibility that the PDUFA date could be moved back, I don't think any "issues will arise from the adcom that the FDA hasn't contemplated" would be the reason it is pushed back, because the FDA sets the agenda.
That said, the moving of the PDUFA date or the adcom would not surprise me in the least. I just think if they change any dates we will have no idea why.
Sentiment: Strong Buy
thumbs down all you want......but i will be correct on this. time will tell. i am currently on the "houses" money for 2014. i removed ALL my initial investments over the last four years of trading in 2013 along with the tax i'll be paying in april. who ever thumbs me down? can not more than likely state this....can you? JMHO
Thanks for your insight. While I enjoy reading your rebuttal and others the bottom line is what the FDA sees in the million plus pages it has on the trials. The other main problem is that Al has no business being the spokesperson for the company any longer. He needs to put his ego aside and stop speaking in public and someone more polished and who doesn't sound like elmer fud on his death bed. In other words, Matt should be doing this and not Al.
Some things that Al has said might be hard to understand unless you have been on the trial. You go home from day 1 with this new product after 10 - 30 years of using Novolog or Humolog and what do you do. I know my a1c went from 8.5 to 6s and finished with a 7.1..After getting off Afrezza I went right back to mid 8s. Now I am working 3 times as hard just to maintain high 7s with the constant fear of lows. Yesterday I had a 33 reading 3 hours after insulin. I am on a big workout kick so its due to that but I never had that happen when on Afrezza. So when Al Mann says its almost impossible to have a low you have to understand where he is coming from. Compared to Novolog yes it is certainly much easier to control and manage diabetes so your lows drop. Now for the type group someone was posting about how they had greater lows than their counterpart. No kidding! This is the first time they are on insulin. Most of these type 2s should already be on insulin and guess what? If you put the type2 group on novo as they should be the lows would be much larger than with Afrezza. My docor has done trials with Mannkind before so it was good combo as between him and I but even he cut my dose back when I got aggressive and thats when I went from 6s to 7.1 but still had a huge drop. I was held back as I had to follow protocols in a way but that was the responsible thing to do as nobody has ever taken Afreeza with the new inhaler in such a trial.
i'm with you pharmabrains! as one brain to another.LOL. i'm 53years old and it's pretty hard to fool an old sly dog like me. i've heard 1000's of speaches, pitches, and employee excuses. i've listened to geniouses speak and the "posers" as i call them "posers=pretending to be someone they are not". Al is a great guy, i don't know him personally but he reminds me of plenty of high I.Q folks i've crossed paths with in my action packed life. you all know what i'm saying here. inhale this, take obama or hitler has an example to what i've just typed here. enough said.JMHO
I disagree. Superficially it's good to have a good speaker for the company. But I prefer to hear it directly from the commander in chief, not from some 1 star general. You'd only get canned remarks from anyone but Al. I can assure you that the Adcom panel will feel slighted if they send COO Hakan (as good a scientist as he is) instead of Al, the man behind it all. I will sell all my shares if they ask CFO Matt to address a panel of renowned scientists.
4. The increase in hypoglycemic events in the type 2 trial is not that difficult to understand, though it is not something that is easy to explain in front of an audience. Here’s my explanation: The early type 2 patient in the Afrezza trial still had a reserve of beta cells sufficient to at least meet basal insulin needs. However, their pancreas’s ability to control glucose associated with a meal was deficient and that is the reason they were no longer controlled adequately even with the oral medications. So, if the patient took Afrezza earlier than they should have, it is possible that the Afrezza dose added onto their natural basal insulin level was sufficient to cause hypoglycemia since there would not have been sufficient glucose to counterbalance the surge in insulin with the drug. I believe this is the situation where there must be reasonable care to coordinate the timing of the insulin administration and food intake. That situation is considerably different than the one diabetics face today, in that they must “calculate” how much insulin to take in anticipation of the type of meal they plan to eat and that is no small task, especially when eating at a restaurant. For an Afrezza user, there is considerably greater latitude in matching the amount of insulin with a meal than it is for a person taking injected insulin.