Biotech Values

[tinkershaw]

could MNKD have received FDA approval if it had limited the NDA dossier to the old inhalation device?

That is a very valuable question to have answered. Odds are that the new device is an improvement over the old, and if the old device would have been approved, the new one will be.

The big question is why did they make this ill conceived switch so late in the game? Even I could see that this would lead to disaster. Was there some compelling reason why they could not proceed forward with the old device, and upgrade the product down the road?

With the Exubera safety results due out later this year, Afrezza may find more FDA hurdles if anything material arises from the Exubera safety study. As the FDA has shown, with bydureon for example, they will keep moving the goal posts on you.

There are some issues here that need analysis as there is potential here (if you are patient) for some outsize gains (or at least the potential) at a risk that is far less than is priced into the shares.

But it depends, IMO, primarily, on the drug working and the drug working safely. If so, it is just a matter of time as Mann will probably continue to fund through at least the next NDA.

This is one reason I like biotechs, for circumstances like this that develop.

Tinker