Partial Approval

[silentbob]

I have seen some doubting if partial approval is possible (notably Adam F).

This is of note since Type1 approval is being questioned (more on Type1 later).

I think most realize that such speculation is nonsense.
Indeed, the FDA itself specifically asks panelists on voting separately for the two indications.

In fact a very common strategy for drug approval is to go after a smaller market first and do studies for label expansion after approval.

That this would not be the case for diabetes is baseless in my opinion. I can't find any logical argument to support that hypothesis.

Did anybody else find a plausible reasoning to support it?

[jpg]

Oral diabetic medications are approved for type 2 diabetics only. Why could Affrezza not follow in the same footsteps if judged to be where the data leads the panelists and FDA? It woud be illogical to deny approval for one group of patients because data in another group of patients isn't robust enough.

As for the conversion issue I don't understand the FDA enough to know if this is a big deal for them but as I tried to point out on another tread these 'hard and fast' conversion equivalences are clinically and biologically simplistic and only guidelines especially when there is a biomarker to base dosing on (examples: INR for warfarin and glycemia for insulin: sc or inhaled).

[notamnkdmillionaire]

Why would the FDA ask MNKD to include a study for Type 2 after the 2nd CRL if partial approval isn't an option? The reason is it is an option. I wonder if the FDA asked MNKD to do a study for T2 because they felt it would have a better chance of approval than T1? But then again, we know something was in the works for initial approval prior to the device change based on insider trading info with the FDA chemist. And if I am mistaken please correct me, but didn't the FDA have a hand in helping MNKD design the trials? How exactly would it look if the FDA denied the drug due to poor trial design they had a hand in designing?

[silentbob]

I agree with you guys, but I am really looking for good contrary arguments... if they exist.

[StevieRay]

Does anyone know for certain if we are only approved for type 2 do will still get the $40 million from Deerfield?