Biotech Values

[RockRat]

OK. How do you think receipt of a minor versus major deficiency letter squares against the possibility of T-enox being Lupenox? I would think Lupenox would have invited a major deficiency letter, based on #3: "3. New analytical methods and full validation data (21 CFR 314.94(a)(9)) " And also #1, specifically "Unacceptable impurities or impurity levels (21 CFR 314.94(a)(9)) (the wrong kind of "junk").

Regards, RockRat