RE: Negativity26 Nov 2020 15:35
The FDA has reviewed the SNG001 pre-IND materials including preclinical and Chemistry and Manufacturing Control (CMC) data, the results of the Phase II study in COVID-19 patients and the proposed Phase III protocol. The FDA has provided Synairgen with guidance on the Phase III clinical study to support the potential registration of SNG001 for the treatment of COVID-19. The Company plans to file an IND application as soon as possible to allow the Phase III study to be initiated. Synairgen will continue to work closely with the FDA as development continues.
Need to know when IND filed -RNS (but we have not has an RNS to say its been files ?)
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
Then informed of RNS first patient dosed on trial.
I believe all this will be done before end of Q4 and will get lots of news end of January.
Big Pharma will be watching every step !!!!!!!!!!!!!!!!!!!
RM is doing great job. EMA and FDA operate slightly differently. I do think we should have received an RNS as soon as FDA confirm as per 21 CFR IND, so can only guess that not received yet ??? Thoughts