Mast Therapeutics, Inc. (MSTX)

[daddybird292]

What's the odds of Culley sweet talking them?

I've listened to the CC a few times, and I have to say he's kinda wishy-washy on this.

He talks about meeting with the FDA ASAP, and hopes he can convince them to take data from the first lab.

If that happens - great. It fixes everything.

In the same CC he mentions a couple times that the FDA's new rules of 12 months maybe being in effect and that delays them several months. He goes on to say they con't throw money at the problem, that only time can solve it.

From the FDA letter
"In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period"

It sounds pretty clear to me, what the FDA wants.
Then again - I don't know how scatter-brained the FDA is.
Do they reverse decisions often?
Has anyone seen a reject to file for this reason?
I tried finding a like situation on the internet - but only found reject to files based on formatting errors and additional info required.... not manufacturing data.


-DB