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Re: roiresearch post# 333371

Monday, 11/16/2020 5:03:16 PM

Monday, November 16, 2020 5:03:16 PM

Post# of 403545
I don't want to get into conjecture and timelines.
I literally have paper timelines for this company-progression spread all over the far end of my dining room table, and every single one of them I've outlined has been blown to pieces.

We have no idea with Leo, when things will get filed and what the response will be. I'm feeling like the FDA is moving faster than usual through CTAP to review IND submissions currently.

I'm also feeling like the results from the RBL are pretty comprehensive and compelling. Possibly more compelling (significantly) than many other prospective molecules coming before the FDA?

W/respect to foreign review processes... I don't even want to hazard a guess. All bets related to timelines are off for RU I think.

In places where speed can be 'negotiated', the sky is the limit.

Given pandemic-urgency, I'd like to think that time-is-of-the-essence.

Were it me, I'd consider some sort of license percentage-contribution for the country stockpile as a percentage of Net, perhaps... in lieu of cash-upfront?

The Russian regulatory environment for obtaining clinical
trial authorizations is relatively complex and somewhat
unpredictable
. The regulations often lack descriptions of
specific requirements for certain documents or processes,
which leaves room for various interpretations of the
regulatory requirements by the industry and regulatory
authorities. Despite the fact that regulations define
specific timelines for review of regulatory applications and
issuance of approvals, the regulatory timelines are not
followed on routine basis.



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