Biotech Values

[mouton29]

<<Even if we assume that FDA approval(s) of generic Lovenox issued prior to 5/16/10 will contain a carve-out for the STEMI indication, the carve-out would be clear-cut and it would not seem to be a matter for negotiation between the applicant and the FDA. Hence, the existence of a label carve-out does not fully explain Bill Marth’s comment on yesterday’s CC, IMO. >>

I'm not sure that Bill Marth said there was "negotiation." He said:


" We’re getting very normal questions back around labeling and all the typical stuff."

That could be interpreted to include a simple discussion about a STEMI carve-out.

Admittedly, this is not clear, but I fear (as a MNTA long) it is as least as likely an interpretation as yours.