Afrezza, success or failure, what do you think and why.

[BlueCat]

Mar 31, 2016 12:40:03 GMT -5 sccrbrg said:

Mar 31, 2016 11:54:15 GMT -5 BlueCat said:

I'm for balanced view. But let's make it balanced and fair. Saying MNKD mgt has mostly failed across the board is not fair, IMHO, and especially in light of the drug itself. That has been clearly demonstrated as a resounding success, and hopefully the results to be shared this summer will substantiate this further.

My .02

Just a hunch, but I don't think the results shared at that conference are going to be the fabled "Superiority" results that we are all hoping for - and if it is, I would very seriously question management's intellect.

If they are sitting on bombshell information, the correct thing to do would be to announce it as soon as possible and start working on a label change and insurance coverage. They would have to be completely inept to sit on that information for months in a precarious cash position just for the sake of unveiling it at a conference. 

Heck, they could release it the day the rights transfer back to MNKD and re-discuss it at the conference and have the same effect.

For these reasons, I think that all we are going to see is a substantiation of the current non-inferior label, which is a bummer.

I don't think its the fabled Grail of Proof.  But also not just a restatement of what's already known.  

I think it will be progress. Perhaps an important step to supporting that larger case.  I'm guessing this is a bit of a chess game and with what the FDA has done to structure what studies, when, their financial resources to conduct studies, etc - this will take some time to unwind.

While we have been down the path of hearing the MNKD mgt team be positive on things that turned out not so positive, I don't think this is one of those cases.  Matt seemed positive about these results, but not over the top.  And unlike SNY partnership results, this one is much easier to predict.

[matt]

Mar 31, 2016 12:40:03 GMT -5 sccrbrg said:

Products are always non-inferior, until they aren't. The reason so many products come to market with a non-inferiority label is because it is easier to prove that A is not statistically different from B, while it is harder to prove that A is better than B with 95% confidence. The statistical formulas are not on your side when trying to prove superiority so it takes a very large trial with very many subjects to prove that A is better than B, and small companies with modest balance sheets are not in a good position to fund such trials which are a prerequisite to getting a label change. It may yet happen, but not for the next several years unless Matt can plant a fast-growing money tree.