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Regulardoc

02/18/17 2:22 PM

#16755 RE: GD #16754

I had the same thought.

If Pfizer is involved with the 20 mg dose and if it is being done at the same facility, you have to wonder what the heck is going on here as I would assume the process should be similar.

Also would be nice to know during the conference call, when PFE first received communication from the FDA that PFE processes were out of compliance. If a warning letter is the third stage in the FDA's notification, what if anything was done to address the situation earlier?

DewDiligence

02/18/17 4:03 PM

#16759 RE: GD #16754

Is the [PFE] facility used for both 20mg and 40mg?

Yes, according to MNTA’s PR (#msg-128816493):

The Pfizer facility is a key part of the supply chain for the Company’s Glatopa products [plural].