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joethdo

09/19/11 3:51 PM

#126815 RE: DewDiligence #126801

I think you hit the nail on the head.

Is MNTA's moat smaller all of a sudden or is the FDA giving in to political pressure and approving something that is not as good as MNTA's product but simply good enough? (I would like to think that's not the case but it's hard to argue that the FDA is completely immune from political pressure.)

Another thought: MNTA's moat might be smaller because other companies have been able to replicate its PATENTED processes which means MNTA might spend a lot of money on lawyers to expand the moat once again. As someone who has invested in an IP play (TIVO), this is not something I would hang my hat on as an investor.

Dew, how long until launch do you think?
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alertmeipp

09/19/11 8:59 PM

#126856 RE: DewDiligence #126801

>> I am somewhat concerned about what Amphastar’s approval means vis-à-vis MNTA’s proprietary technology.

I agree - but we are not paying much for the technology. I think we will see more from the forthcoming suit.

But at minimum, there are still competitive advantage to the technology.

The good thing today is that the big uncertainty is now removed and we can wait for mC and FOB to come.
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biomaven0

09/20/11 3:44 AM

#126883 RE: DewDiligence #126801

because the FDA lowered its standards—perhaps in response to Amphastar’s high-profile lawsuit against the FDA



Well in Amphastar's lawsuit, they said that they had already achieved "sameness" under the FDA's 5 criteria. So that implies the hard lifting had been achieved prior to the lawsuit.

My bet with you is still to be determined - it was Teva-specific, not based on any generic. Around another 2 years to run I believe.

Peter