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Tuesday, October 20, 2020 6:38:29 PM
The timeline is the issue. As Nader indicated best case scenario for next interim analysis is 4-6 weeks to enroll 63 more patients plus 42 days on drug. That means 10-12 weeks from today. That tells me by the time data is compiled by the DSMC we are 12-14 weeks out best case. Realistically four months would be a hopeful timeline for the 75% interim. That’s Feb. 20, 2021. If DSMC recommends that trial should run to completion that means going deep into Q2 2021. Those are the facts.
During the wait Nader must come through and complete BLA. Hopefully he has hired a competent and experienced firm/individual to jump on this project full time and get it done. Success on the BLA front in 2020 as promised is essential to maintaining valuation and raising $.
The pursuit of international approvals are nothing more than hope and window dressing. This is about getting it done w the FDA right here in the USA.
We are the little engine that could — and likely will. Strong on science and short on horsepower.
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