Replies to post #119776 on Biotech Values

[investorgold2002]

how heterogeneous are biologics

for ex: EPO - is there a lot of batch to batch variation like Lovenox ?
anybody here ?

[DewDiligence]

MNTA—THIS IS BIG. First time I have heard that human testing of any kind is not mandatory. Even Momenta was stating some clinical trial maybe needed on biologics.

Hold your horses! For the kinds of FoB’s MNTA is likely to be interested in—e.g. mAbs—limited clinical trials probably will be required, at least initially. The FDA’s waiving of clinical trials is most likely for the relatively simple proteins such as the interferons, ESA’s, and variants of G-CSF.