Replies to post #99123 on Biotech Values

[ghmm]

MNTA:

Thanks for providing the updated analysis.

For the most part I had been happy with Wheeler but I think he really dropped the ball by waiting out the FDA (on M-Enox) to partner M118. It reminds me a bit of what Givens (ENCY) did with the just a little more data and the FDA will be happy. I think its too hard to run a company trying to time it with FDA decisions. I would have been happy with a partnership where they pay development costs and we may not get up-front money and say a descent royalty instead. Granted I have no idea if he could have gotten such a deal so perhaps he is doing the best he could. I get disappointed with management letting things sit even if we have to give up some upside to keep it going.

[jb_118]

re MNTA handicapping. How are you using the terms "undecided" and "rejected"?

How do you break out formal communication requesting additional information (generic version of an Approvable Letter) from the current situation where we seem to be in limbo? Is that rejected or undecided?

At this point I've assumed that the FDA is trying to figure out what their criteria/standards are for approval. Once they get that figured out it should be somewhat simpler to determine which applications meet the standard, since they've likely been through the applications backward and forward trying to work on a standard. I've kind of assumed a relatively contemporaneous response to all three companies.

If "undecided" is taken to mean the current state of limbo, I would think it relatively unlikely that one company would get a decision and the other wouldn't hear anything. Your probabilities suggest >50% change that if MNTA gets a decision, TEVA remains in limbo. I might be thinking of "undecided" differently than you are using it. Could you elaborate on your thinking?

[go seek]

MNTA: Now the Big ? is...
Will Teva's Lovenox ANDA be approved and if so when?

Any probabilities on that one? :-)