Replies to post #79201 on Biotech Values

[PSA declining]

Very unlikely FDA to recommend running human trials when they had every opportunity to do so last year. Plus why would FDA spend a substantial amount of time inspecting the 4 plants in China if they had the notion of recommending running human trials on the horizon?

If the ass-backward recommendation of running clinical trials is made now it would be devastating to the immediate and near-term share price because I don't think anyone close to the stock anticipates that being a real possibility.

Just waiting for the Volcano to erupt!!

Thanks

[DewDiligence]

MNTA: if one of the worst-case scenarios unfolds and [NVS] is asked to run a trial comparing its generic Lovenox to the branded one, has it been spelled out how the expenses of such a trial would be split with NVS?

I presume you’re referring to a hypothetical clinical trial intended to demonstrate safety and efficacy of m-enoxaparin rather than merely its pharmacokinetic equivalence to Lovenox. Under your hypothetical scenario, NVS would be solely responsible for the clinical-trial costs; however, NVS’ responsibility to pay such costs is probably moot because I would expect NVS to terminate the Lovenox collaboration for lack of commercial viability.