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Replies to #83396 on Biotech Values
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DewDiligence

09/09/09 7:06 PM

#83398 RE: jbog #83396

MNTA:

What are the chances that the FDA is waiting to not only approve MNTA's generic lovenox but also including Amphastar's and Teva's at the same time.

Waiting for what, exactly? Are you asking about the companies’ supply chains, specifically? Please clarify.

How would you imagine the market chopped up if all three are approved simultaneously?

This is hard to handicap because a lot depends on the knowledge level of investors vis-à-vis the economics of the NVS-MNTA partnership for Lovenox.

FDA approval of the Lovenox ANDA’s from all three applicants ought to be negative for MNTA insofar as it would imply that MNTA’s proprietary technology is not needed to replicate branded Lovenox within the tolerances required by the FDA. On the other hand, wallstarb-like investors who understand little about MNTA’s business and focus unduly on the balance sheet may consider the approval of all three ANDA’s a positive for MNTA insofar as this outcome will allow MNTA to begin receiving royalties from NVS and it will obviate the need for MNTA to raise cash this year.

Lately, it seems that there are a lot of wallstarb-like investors out there speculating in biotech, so it’s not crazy to think that MNTA’s share price could rise on FDA approval of all of the Lovenox ANDA’s. However, I would not expect such a rise in the share price to hold up for long and hence it might present a good selling opportunity.

p.s. To be clear: I do not expect the FDA to approve the Lovenox ANDA’s from Teva and Amphastar.