Replies to post #114233 on Biotech Values

[floblu14]

From Dew -

MNTA:

…characterizing a mix of polypeptides is easier than sugars
Absolutely correct. Because it’s 100% synthetic and has no biologically sourced API, Copaxone is easier than Lovenox to reverse engineer to the lot-to-lot tolerance of the branded product.

If the FDA approves generic Lovenox via the 505j (ANDA) pathway, generic Copaxone ought to be no problem for MNTA, IMO.

Also,

What if the FDA demands human trials for Copaxane?

From Dew's post -

If someone directly asked them "We think there is a logical basis for the FDA to require trials. What do you think?" would we just get more stonewalling (likely, in my view)?

This has been asked and answered on several occasions. The simple and direct answer is that the FDA accepted NVS/MNTA’s Copaxone application for review under the 505j (ANDA) regulatory pathway.

Since the whole point of the 505j regulatory pathway is to allow generic drugs to come to market without clinical trials, I consider the above answer a pretty good one.