News Focus
News Focus
icon url

DewDiligence

10/14/11 2:49 PM

#128462 RE: niles #128460

That includes Amphastar, Watson, Momenta, analysts. and this message board.

Also Chris Viehbacher and Hanspeter Spek, who said on a CC in 2010 that Amphastar’s ANDA should not be taken seriously.
icon url

exwannabe

10/14/11 2:53 PM

#128463 RE: niles #128460

linhdtu's reponse is far better than what I was actually thinking. When I wrote that comment I was thinking about how almost everyone seems to have been completely blindsided by the FDA's approval. That includes Amphastar, Watson, Momenta, analysts and this message board.



Obviously Amphastar was blindsided else they would have been ready for an immediate launch as Sandoz was.

If the sponsor was blindsided, how can anybody else outside of the FDA expect to forsee it?
icon url

biomaven0

10/14/11 3:06 PM

#128464 RE: niles #128460

I was thinking about how almost everyone seems to have been completely blindsided by the FDA's approval. That includes Amphastar, Watson, Momenta, analysts and this message board.



Here's my post from 2010 quoting Amphastar as saying they had achieved sameness and that the remaining holdup was presumably immungenicity and supply:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58179235

Their claim was pooh-poohed by posters on this board at the time, but in the light of subsequent developments it appears it was likely accurate. So I have no reason to doubt that they are ready to launch in limited quantities if the TRO is lifted. I really think people are grasping at straws here.

As far as I am concerned, the only remaining substantial uncertainty is whether MNTA can demonstrate Amphastar is infringing during the testing in the manufacturing process.

Peter