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Replies to #79359 on Biotech Values
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DragonBits

06/10/09 4:29 PM

#79364 RE: DewDiligence #79359

DD, I love the MNTA story, and I think long term they will be a big winner. But honestly don't care much for the stock. The problem with the stock is that too many small players like myself have bought in, and this makes the stock weak.

I much prefer stocks that few know about and wait till they get discovered. I do hold a position in MNTA, but it doesn't seem ripe to move up.

It would be nice to see some sort of surprise positive news, but that also doesn't seem likely.

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osofun

06/10/09 5:20 PM

#79368 RE: DewDiligence #79359

Dew
Regarding the presentation , whats your take on the head of sandoz commenting on possible a longer time line ? (brought up by someone asking questions )

TIA
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iwfal

06/13/09 12:21 AM

#79499 RE: DewDiligence #79359

MNTA - Lovenox FDA approval

the observation that assuring the integrity of the bulk-heparin supply chain appears to be the sole remaining roadblock to approval of the ANDA.




After listening to the conference call I am not sure I would phrase it that way - he said it was the only thing the FDA was currently asking about, but that the FDA has the ability/right to go back as they choose.

On a more basic question. If the FDA is really buying in on the exactness of Momentas duplication (which, per the speaker in the cc, is perfect, so that it is absurd to run an immunogenicity trial) then why did the FDA ask about immunogenicity and hold up Momenta for 2 years?

This goes to whether the FDA really believes Momenta when they say the duplication is exact. Whether the FDA is capable of ever believing that it is exact.