Replies to post #118439 on Biotech Values

[jq1234]

To me ABT and GSK are long shot, not because they are not interested, but because AMR101 will overlap with one of their existing drugs. To buy AMRN today will be quite expensive for a drug that needs outcome trial substantially underway before filing NDA. It doesn't seem it is as attractive to these two as to say others like PFE, MRK, AZN from my point of view, thus I highly doubt they can outbid other big pharmas in similar space.

[investorgold2002]

"“substantially underway”"
When asked FDA means by that...
I believe in one of the cc's they said they should be in position to do this by 2nd quarter 2012. Keep in mind in their april cc they said they are almost done with design of CV outcomes trial and they are talking with number of global CV experts to put final touches to this outcome trial design. they also said, 5k patients would be enough. And they also mentioned it wouldn't be hard to find/enroll 5k patients(the type of patients for this trial) in accelerated period.
I think 2nd quarter 2012 is still aggressive but this company of 22 employees has a trail of over-achieving and under-promising.

[investorgold2002]

"unless the FDA relents."

http://www.investorcalendar.com/IC/CEPage.asp?ID=164219

Yes. Joe talks about potential flexibility with FDA wrt "substantial underway"

"we have been having several active dialogue with FDA on a question on "substantial underway"

there is flexibility beyond SPA"