Replies to post #16956 on Momenta Pharmaceuticals, Inc. (MNTA)

[anotherbiotechguy]

Thanks for the update. The "may" carrot doesn't do much for me. If all else except for fill/finish is presumably good to go as has been implied, it would seem we have left the realm of "may" and entered the realm of "did."

[radford]

I doubt that the use of the word "may" by FDA was directed at any particular product. I do think it is possible, however, that 40 mg Copaxone could be considered to be more of a line extension than a new product introduction since they are both filled into the same size syringes. Purely speculation on my part. That said, my take on the warning letter is that FDA was delivering a strong message about inadequate quality oversight across the network of Hospica/Pfizer fill/finish plants. When Craig said today that Sandoz/Momenta was considering all options, I would expect that they are looking seriously at transferring this to another site. If there is a suitable facility available, it would be a fairly straightforward tech transfer exercise.