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Re: None

Monday, 11/16/2020 4:40:15 PM

Monday, November 16, 2020 4:40:15 PM

Post# of 402700
According to the new Law on Drugs, foreign sponsors
may apply for clinical trial authorization under two
circumstances:
1. As part of the registration process for a new drug in
Russia (marketing authorization) or,
2. As part of an international multi-country study (if is
the study is not conducted for purposes of registration
in Russia).

I assume IPIX would go with Option 2. I think someone picked up on the fact it doesn't specify which "multi-center" will be the first to enroll humans, or better yet, WHERE

Seems like if Russia is the place, and we can pinpoint this date:

The NEC
reviews the application during their routine committee
sessions which is typically held once a month. Decisions at
the NEC session are made by simple majority of members
present at the session.


then we can take a better guess when the first human patient will be dosed with B for C

Here's a nice easy read (even for me)
https://biomapas.com/what-you-need-to-know-about-running-a-clinical-trial-in-russia/

the above is all IMHO (consider this my safe harbor statement)

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