Replies to post #6010 on Momenta Pharmaceuticals, Inc. (MNTA)

[flatlander_60048]

Amazing that in the 6 months since the FDA rebuttal on March 15 that Amphastar was able to quit slinging mud and address all the deficiencies identified by FDA.

Perhaps Kroll was able to come up with just 1 or 2 incriminating photos, or perhaps political pressure was brought to bear from another source. Either way we will never know.

FL

[joethdo]

It's interesting to look through these documents in light of Amphastar's approval.

a) It does seem -- if you take these documents at face value -- that the main thing standing between Amphastar and approval was its inability to get its Heparin supply in order. Once the FDA determined the supply was safe, approval must have come fairly rapidly.

b) However, given the way that Amphastar sourced its heparin initially (through a front company) and given some of the other bizarre stories about the company stalking FDA officials, one must wonder about their overall capabilities. This is obviously a non-scientific gut feeling.

I bet Momenta can't wait to analyze Amphastar's Lovenox. (Of course, that would imply a launch of some kind and we want that to be held off as long as possible.)