I've been in contact with Matt off and on the past few days, and here's what he said when I CCed him on Rapps feeble last gasp attack today:
This is a pretty good example of what I was talking about in my last message. No matter what you do, it is impossible to stop postings like this and impractical to respond to all, most or even many of them. And once you start trying, it is hard to stop.
As near as I can tell, this person is making things up as they go. He seems to have insights into what the FDA wants that we don't have and in fact are contrary to what they have told us. They also don't make a lot of sense. He also seems to confuse us with basal insulin. We are not basil insulin. Fasting blood glucose improvement is not something prandial insulins have ever been required to demonstrate. The same can be said for any periods not related to mealtime glucose excursions. It is a bonus that we often do lower fasting levels, notable mostly for it not having been seen before with prandial insulin. Obviously, this is not an FDA requirement, as it certainly has never been required of any existing prandial insulins on the market.
Happy investing, all.
Matt is the one confused. He doesn't get the concept of what MNKD tried to sell to the FDA. After the last CRL the excuse for not having better A1cs was that basal was not being sufficiently titrated. They sold the advantages to FDA as Afrezza having a shorter tail thus you could treat-to-target those patients with more aggressive basal titration. You couldn't do this w/ RAA's b/c their longer tails would cause excessive hypos.
117 was also a non-inferior trial and Afrezza ended up doing .07% better v. aspart. FDA wanted better efficacy and bought into MNKD's forced titration theory. By signing off on monitoring and forced titration, FDA essentially said, 'O.K. we're giving you a new chance to prove your theory, but we expect you to do much better than last time.' Al hoped for superiority and expected to see clear improvements over 117.
The theory failed. Not only did fasting levels get worse vs. 117, but overall A1c's got much worse also. Not only with Dreamboat, but Medtone as well (.08 mean change vs. DB proves this).
Matt, what's your excuse now? Why don't you answer the real question posed in Q&A # 6 and admit that late post prandial and evening bg levels are much higher in Afrezza arm vs. aspart arm. Admit forced titration and treat-to-target theories didn't work. Admit you were supposed to get better vs. 117, but failed. Admit you were just .05% at 95% UL threshold of losing EVERYTHING.
Al Mann Q2 2012:
With our current study MKC-171, we are targeting this issue head on by requiring the fasting glucose level to be lower to under 110 milligram per deciliter, unless there is hypoglycemia. In earlier trials, even with AFREZZA cohorts, clinicians have generally not increased basal insulins to adjust fasting glucose to goal.
In the Affinity trial, the FDA has authorized us to engage an independent monitor who will review e-diary records and will contact the clinicians responsible for patients that are not complying with the protocol.
" O.K. we're giving you a new chance to prove your theory, but we expect you to do much better than last time. "
So FDA wanted to them to do much better.. but then.. FDA itself set the endpoint goal of non-inferiority and not "Superiority" and, set the goal of between group difference of 0.4. So help me here.. Why did FDA was so easy on setting end point limits? May be they decided that lets set lenient goal and then reject the product on the grounds that they didn't show superiorty.. Hummmm..... FDA for sure is known to trick companies in to this kind of situation in order to derive fun of rejecting products... I know.... All of us know that...
Nice try... my commitment to you Rapp78.... I will keep bumping my famous post to the top of the list until you stop posting your baseless posts or change the ID so at least I can tell my self that you finally left the board. ! :-)
Yeah, the company representative is confused - the guy close to the science - and you are the scientist among us. I've had about enough of your garbage, Rapp. I hesitated to ignore you previously, but now you're just a noise that is annoying me. Goodbye. I wish I could say good luck, but hey - goodbye.
You state that " Admit you were just .05% at 95% UL threshold of losing EVERYTHING. "
Please the range of values that would not cause the hypothesis to be rejected at the 95% Cl threshold.
I suspect you have no idea what you are talking about. In your opinion is the .07 mark a mean or a difference?
Rapps arguments have always been very weak. I have caught him making up things on the fly. My questions to him are. What are his intentions? He is smart, and we are dumb? He has a higher command in the field of biostatistics, that we? He can post glittering generalities and because he uses (actually regurgitates) technical terms, we are to believe him? My only conclusion is he is trying to manipulate the traders and investors on this board into believing "something is rotten in Denmark". What a sorry way to live a life, when there are diabetics out there who could use Afrezza and possibly change their lives for the better, even possibly much better!
Everyday something more positive. How long will it stay down. Till one evening boom, the news hits and in a few minutes the green just keeps a gushing. Boy, it sure would bite to be short at that moment. Can' t understand why there are so many of them.
Thanks for sharing...good to hear quality responses to self serving idiots like Rapp. If only these idiots had compassion for diabetics who truly need this solution. Time is all we need.
Sentiment: Strong Buy