Sorry it was so long. I wanted to really try to explain this to people so they don't get scammed out of anymore of their shares. The trial results data was fantastic for both trials, and do not let anyone try to convince you otherwise...
Thank you for all the information. You made it easy. I a, a new poster but I have been a long time accumulator of the stock plus have some 2014 and 2015 calls (that are fortunately still in the money...just). My question is related to the two other measures you identified....the glucose and the hypo. Can you complete the picture by telling us how these two measures along with the a1c measure adds up to superior to injection? Again thank you for all the time you put into this and thanks in advance to your response to this. This is a sincere post by a concerned long (well into 6 figures).
Actually Afrezzauser (I think that's his moniker) who participated in one of the clinical trials had a really great post explaining from an actual users point of view. However, to quickly summarize, both other measures demonstrated a statistically significant improvement in glucose control as well as safety (e.g. reduction in highs and lows).
Also, in the 175 trial, per Dr Mann in the 1st quarter conference call, an improvement of 0.5 percent was the requirement, in the A1C level reduction for individuals using Afrezza over a placebo. The actual trial results showed a mean A1c levels decreased by 0.82%. Significantly better then what was needed for the trial to pass.
Plus in the 175 trial, when compared against other non-insulin diabetic drugs, Afrezza lower the A1C by almost double the amount they did.
Basically, Afrezza kicked in the door, and showed it will be a great improvement in the treatment for T2 diabetics, as well as T1 diabetics.
TOTALLY AGREE PFG..this is scaremongering at its highest level..people just do not see what is going on..only fear & the current situation is what retail sees..
this is being driven for one reason..
TO DRIVE THE PPS RIGHT BACK UP AGAIN...
its a no brainer the tech & drug will be approved..it willl make billions &
ONLY fools & people who havent done their homework will miss out here...
the past 3 days is no coincidence this was done for a reason...
I BELEIVE & AGREE SOMEWHAT with bbarra...this company is going to be sold ..
AND THE WHATEVER resources the potential buyer has of doing this is presently at work...
LETS SEE what transpires over the nes=xt month or two & if this does actually happen...
best of luck
Really short summary. Afrezza's improvement in glucose control led to a CATCH-22 when measuring changes in the A1C level. Better control lowered A1C, but better control also likely increased the red blood cells average lifespan which results in an increased A1C measurement. This would be highly supported by the great results shown in the other trial measurements. Control means here without all the wide swings (e.g. lows and highs) as reported by the comparative meal time insulin.
The FDA understands this data which is why THEY and not MNKD set the deviation allowed (0.4 percent). In fact this is almost the same identical results as shown in the 102 trial by MNKD. The FDA accepted the 102 trial data, never raised even one concern or issue about it in the prior CRL's (why would they the difference was not significant as defined by them).
Doctors who treat diabetics will understand the trial data was outstanding, and certainly so will potential big pharm partners.
There is billions upon billions of dollars that will be made by investors when Afrezza is approved. In addition they will easily secure a big pharm marketing partner, and this drug is going to be a blockbuster. Wall Street understands that, and you are watching exactly how dirty they can get to scare the retail investor in giving up their shares.
I understand that most retail investors do not do nearly the due diligence they need to, to prevent things like what we are seeing from happening. Part of the reason is they simply do not have the time, as they have other full time jobs. However, there are those that have the education and the time to understand what the big boys are doing.
What we are seeing has happened to many other biotech stocks, so to think the PPS short term movement is an indicator of any thing is rather naïve. If my post helps even one person feel a little better about their decision to hold, then I am happy to have put the time in to enter it.
I am long on MNKD, the trial results were excellent, and I could care less about these silly bear raids. They are not costing me a dime, and hopefully some of the retail investors are taking advantage of them to increase their holdings.