Replies to post #114231 on Biotech Values

[zipjet]

Thanks Peter,

I agree we do not know what FDA will do. FDA has in approving mL shown some willingness/preference of characterization (by a combination of tests) over clinicals. My guess is that will continue with higher levels of characterization where as here (mC) the MoA is less clear. Whether FDA favoring characterization is driven by statutory restraints, or a sense that starting clinicals would pose time-bottleneck, or prove a financial killer for generic development is unclear.

C is a mixture of molecules and in that is like L. The label for C defines the share that each of the components of the mixture represents. So getting that right, has a target, and lot-to-lot variation of C offers a range within which to define success.

I too have to think that tL is on the horizon without knowing the distance. Were Teva to stumble, it would be a major positive surprise to MNTA holders.

ij