Momenta Pharmaceuticals Inc. Message Board

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Biotech / Medical : Momenta Pharmaceuticals Inc.

MNTA 52.48

0.0%

Oct 2 5:00 PM EST

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From: kenhott	11/2/2010 5:14:03 PM
	of 3027

Here is one way to think about this situation. Instead of only trying to figure out if Teva will get approved eventually, maybe it would be useful to cut the time-line into more manageable size pieces. And for some of us, it would be useful to get an idea if Teva will get approved in the next 3+ months, for instance. So if we look at the next 3+ months, neither Teva nor the FDA are likely to come out and say that the Teva drug is in trouble or rejected, etc. Why? Teva can kind of keep the lid on something negative and the FDA is in the cone of silence. Looking only at the impact of the Teva drug, the upside case for MNTA is more of the same with a bit of an upward price bias in this time period. The downside case in the 3+ month time period for MNTA is Teva approval. Since the upside case is more of the same, let's focus on the downside case. Both MNTA and Teva can say all they want, but it is the FDA that counts here. So maybe we want to look at the FDA decision making for the Teva drug assuming the Teva drug is ready for approval which is the downside case. I suggest two columns. Mark one >Reasons why FDA would approve in the next 3+ months. Mark the other >Reasons why FDA would probably not approve in the next 3+ months. I will throw in a couple of reasons... On the Reasons Why side: If the data fit, you must approvit. On the Reasons Why Not side: This is the first approval of a complex drug of this type. Maybe smart to wait and see more live safety data for M's enoxaparin before approving T's. M's enoxaparin was approved in late Jul 2010. So if you take the time-line out, six months forward is late Jan 2011. Maybe smart to wait a little bit before approval of T's given the active SNY lawsuit. People are already getting the "cost benefits" of having an enoxaparin generic. I have a couple more reasons on both sides but I will stop it here. Everyone can come up with his/her own columns. And from these reasons, maybe each of us can individually take an educated guess at likely approval of T's drug in the next 3+ months. Don't forget to add back the assumption that T's drug is ready for approval. Good luck. I am heading back to my parent's basement. Hey idos, thanks for the info.

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