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Re: wsbc post# 333269

Monday, 11/16/2020 4:30:04 PM

Monday, November 16, 2020 4:30:04 PM

Post# of 402706
OK, so let's assume Russia is where the CTA was submitted

The paper suggests having a local CRO " expertise of local regulatory experts to
ensure proper navigation through the regulatory process." Biorasi apparently is a CRO

The regulatory process starts with submission of
the application to the MoH. Once the application is
received, within 5 working days the MoH shall review
the completeness of submission and, if the application
is not found to be deficient, shall forward it to the NEC
and SCEMP for review or, return it if the application as
incomplete or otherwise deficient.
Upon receipt at the SCEMP the application undergoes
review by different expert group, including experts in CMC,
toxicology, pharmacology, clinicians, etc.
At the NEC the copies of application package are
distributed to the members of the committee. 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.


Any idea what date the NEC will be reviewing Brilacidin's app (if of course Russia is the overseas area mentioned in today's PR

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

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