Replies to post #64138 on Biotech Values

[DewDiligence]

>If approved, does Sandoz launch "at risk"? I would vote for yes.<

Make that two votes for Yes. I think this has been NVS’ game plan from day one.

>Good news is there's a second product to value and the analysts that had "everything ex-lovenox" at a dollar or what not will need to rethink.<

Correct! Moreover, we now know that MNTA/NVS have first-to-file status on Copaxone.



Let’s talk biotech!
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

[ThomasS]

MNTA: Imo, there will be a third product, shortly, when M118 PII results hit. The good news is that it may be the biggest of all.

[Biowatch]

Re: MNTA and CP delays for ANDAs

Is there a "typical" length of time that filing Citizen Petitions works in slowing down the approval process for generic drugs?

Is there even a ballpark figure / best guess estimate for a small protein product? (Or larger proteins.)

In a general way, how will it affect "follow on" biologics that involve a highly characterized (in terms of glycosylation) small protein such as Copaxone?

How well do boilerplate CPs work if a particular company wants a generic drug approved (or not)?

How does the increase in generic drug applications versus the flat staffing levels in OGD factor into the equation?

Disclaimer: I used to own NSTK (now MRNA), and their Calcitonin ANDA is still in CP / approval limbo/purgatory. Fans of the stock assume the FDA is at fault. Cynics might think otherwise. Hard to tell from the outside.

However, the money spent to have a lawyer file a CP that delays an ANDA approval is pennies on the dollars lost by having generic competition on the market.