Silentbob

[spiro]

Welcome to the board, I am glad you found us. This is a great board, with a lot of good people posting. i am not too concerned about the Deerfield situation and find it mostly a distraction to the real issue of whether or not Afrezza gets FDA approval. It would be great if you could share your opinion with the board, regarding the results of the 171 and 175 trials. 

[silentbob]

Thanks Spiro. I'm not concerned either. Dilution is dilution and in the long term it doesn't matter who holds the shares.

Could you be more specific on what issues you want my opinion on?
I don't have the time to do a 10 page general write-up right now!

[spiro]

Ok, IMO  type 1  is a slam dunk and will be approved. Do you think the type 2 data is good enough for approval? What issues do you think the FDA may focus on with this data? 

[silentbob]

Well the type 2 trial succeeded in spite of a strong placebo result, didn't it?

Is your concern about the .4 difference where MNKD hoped for .5?
The FDA didn't ask for .5 as far as I know. It was chosen by MNKD as a goal for purposes of calculating the number of patients needed to achieve statistical significance in the superiority measure.

Turns out the p value was very low and the trial would have been sufficiently powered even with less patients, and with a lower between group difference. That is somewhat disappointing but seems irrelevant to approval.

My personal view is that the FDA asked for starting A1C's that are way too high. These people should be on basal as well, and that is not Afrezza's function. In addition, HbA1c is a very poor measure for true prandial insulin evaluation. It works well for the older 'rapid' acting insulins only because their long tail acts as an basal component - a dangerously unstable one.

Yet Afrezza completed the trial successfully in spite of these difficulties.
What's not to like?

I'm not going to do a write-up on the full trials, but if you want to raise specific concerns about certain data points then I'll take a look. Please don't make your questions too general?

[vrtl1999]

Hey bob,
In your opinion what issues do you think the ADCOM/FDA would have grounds to grabble with? I guess what I'm asking is, what are the weakest points of the NDA (study results) that concern you?

Thanks

[oncostat]

I think that the AdCom was requested because the type 2 (much larger population) is now being considered in the label... not because it is considered as a new class of insulin.

Oncostat

[babaoriley]

Good to see you here, Oncostat! I believe bringing in the Type 2's is a significant reason for the AdCom, and a perfectly legitimate one.

[nemzter]

You guys are completely wrong - according to our expert (Adam F.)

"Maybe MannKind totally mis-read the situation and FDA always intended to convene a panel for Afrezza. Or, maybe some time between last fall and January, MannKind received feedback from the FDA suggesting the agency had serious problems with the new Afrezza phase III data. MannKind, desperate to rescue Afrezza from a third rejection, then asked FDA to schedule a panel -- something drug sponsors are allowed to do."

[babaoriley]

Heck, nemzter, sometimes we just fail to see the obvious! LOL!

[rak5555]

I agree w/ Oncostat. They array of treatment options for type 2 is much broader than type 1, which raises multiple complex labeling issues. If the Adcom agenda is oriented towards labeling for type 2's mnkd should do well pre adcom.

[alcc]

If you read the Exubera adcom transcript you'd find that adcom voted 9-0 for T2 label and 7-2 for T1. During the Q&A there were several comments to the effect T2 is a no brainer. That adcom expressed no reservations whatsoever re T2. I don't see why it should be different this time.

Afrezza is superior to Exubera in every way except re A1c. The bad thing re Exbera is that its mkt failure set a negative precedent that cast a shadow. Otoh, the fact it got approved sets a great precedent. How can they reject Afrezza after approving Exubera?

[silentbob]

Are you guys sure you want me to provide fodder for the shorts by focusing on the negatives here?

The problem I have is that while I believe the negatives are small and should not affect the outcome of ADCOM or PDUFA significantly, when offered without proper context they can be used to paint an unfairly one-sided picture.

The other problem I have is that I do not want to spend many hours composing a post that includes the right context for the negatives, making risk of being misinterpreted even worse if I just post about the risks.

Besides, I only have as much information as the rest of you... not very much!

[rak5555]

First off, welcome back silentbob. I understand your reluctance to go back through all the issues that have already been covered ad nauseam on this and other boards. Given your talent for the more scientific issues, I would appreciate your thoughts regarding the adcom agenda and briefing once it is available. There will be 2/3 fast and furious trading days between the release of these docs and the actual meeting.

[babaoriley]

Right, rak, and judging from the option prices for the March 28 expiry, many are betting that the release of the briefing documents will be a significant market mover. Look at the $4.00 and $4.50 puts for that day!

[mrhaigs]

Look at the difference in call prices though. The premium goes up substantially, almost double, for calls expiring march 28 vs march 21. That's definitely a bullish sign. You don't typically see that kind of behavior in a week with no real type of market moving event such as earnings, adcom, pdufa, etc.