Replies to post #109500 on Biotech Values

[HattieTheWitch]

You thought MNTA had presented a public roadmap to show competitors how to go about attempting to get FDA approval?

Maybe they haven't mapped the "how" directly, but the "what" seems apparent - even to a slow learner like myself!

[iwfal]

You thought MNTA had presented a public roadmap to show competitors how to go about attempting to get FDA approval? LOL

1) I wasn't asking about a 45 page paper (the length of the FDA's response) - just a general outline. But even at the length of the 45 page paper...

2) Are some of Momenta's trade secrets in that 45 page paper? They should sue -g-. More seriously probably 75% of even the multipage piece is very public domain stuff. At least 6+ packed pages of public cites. And none of it is about the particulars of techniques (where Momenta's IP appears to reside) other than cites to very public papers.

3) Having read a few Momenta related papers/patents about characterization they are clearly a whole different level of detail. I.e. if they are willing to publish the papers that they DO publish then why be shy about the more general things that they think are important in characterizing enox?

4) As has been discussed on this board previously - if the other generics didn't 'build it in' then what is the chance that they could pass even if they knew precisely what the FDA's standard was going to be.

Bottom line - providing a 1 or 2 page summary of where you think characterization is necessary and why your proprietary techniques help (but no discussion of those trade secret techniques) seems quite reasonable. That said, it is clearly within their rights not to discuss it - but if they choose that route it should be expected that people like me will be a little more doubtful if Momenta claims 'we told them the route to take'.

PS Apologies for doubting The Word of The Wheeler. And pass the Kool-Aid please.