How much will mnkd management know t1 results by 06/05?
Br, Opc, rt, or who knows the trials procedures well enough, my question to you guys is how much mnkd management can know the results of T1. Since the trial completed (say 05/31 the worst), can the scientists from mnkd draw up some quick conclusions by glancing the raw data reported back from different sites? If so, then I think al or whoever the speaker at 06/5conference will definitely give some hints if the results are positive as they expected. What do you think?
Don't expect specific results before the date they mentioned all along, i.e. August.
Having said that, it is almost inconceivable to me that Mannkind would not have received sufficient input and feedback from centers and patients to have had a general idea of how the trials were going all along. It is equally inconceivable that this information would not have leaked to a variety of people who are connected with Al and other Mannkind brass. The appreciation in share price this year is one clear indicator. Another indication are some of the statements Al has made. In March, in the article published on the 'Insulin Nation' website, Al is quoted as saying "the results will be stupendous". Given Al's penchant for exaggeration this probably means the results look good, hopefully with some superiority. The biggest coup would be hypos with RAA, and no hypos with Afrezza. That could lead to claims language which would open the gates to the T2 market. IMO.
do people inside the company know of success or failure right now...i would say if they did they would not show it in a conference and reading al's body language is rather meaningless as much as reading tea leaves
If they dont have raw data, and they may not have the complete raw data, they will certainly know of participants who experienced any morbidity such as hypoglycemic events and had to be titrated upwards with basal or dropped if they could not maintain FBS at low enough levels. The latter is extremely important, since you do not want any from the injectable group to drop since such participants HbA1c values will be high.
The only endpoint that matters for approval however is bioequivelence of the two inhalers. I dont think a definitive answer will be gleaned at the conference but you will be able to figure it out by Al's giddiness. Certainly Al will share with the audience remarks he has heard from the researchers.
In short do not expect any data to be shared at the conference.
Cp, yes, I will be listening carefully to Al's giddiness. I believe Al is a genuine man and not good at hiding his emotion. I also believe smart scientists can quickly draw a conclusion in his/her mind by glancing through some key data points. The time consuming part is the prepartion of charts and tables for formal presentation. My wild guess is MNKD management will know the conclusion by 06/05 and we may get this message through judging Al's body language during the conference presentation. As a long-term MNKD investor (or better called gambler), i am a little hyped up and also nervous in the same time. To just gain the FDA approval is one thing and to show superiority is completely different game for the price of this stock. It seems to me holding is still the best strategy to make most out of this stock. But I just can not help to think of different scenario and hope someone can provide some opinions and counter-points to balance out my mind-set.