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Monday, November 16, 2020 4:40:15 PM
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:
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)
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
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