Biotech Values

[iwfal]

MNTA -

But they also show that if they monitor their 7 (non-infringing) elves closely, they always have sameness, and going forward they manufacture using these 7 elves only.

I.e translated into real world - that the FDA allows generics to use the same kind of (lack of) process rigor as the original manufacturer. Agreed that, as I've said before, if(!!) the FDA allows the generic to use only the same kind of process rigor as the originator then Momenta patents are worth a lot less.


However I think this is very very unlikely - the FDA has a long history of being (justifiably IMO) retentive about a change in manufacturing even by the original manufacturer trying to duplicate their original elves. (Because they don't really know it is the same elves.)

PS As for prognostication - I agree there are a lot of pieces we just do not know and thus the distribution is large. But based upon Momenta's demonstrated expertise and the FDA's retentitiveness I'd give 50 pct odds of greater than 10% royalties and more than a 1 year delay of launch.