The current mono phase 3 trial is an investigation
Post# of 148187
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Posted On: 01/10/2020 6:24:53 PM
Re: ClosetInvestor #14742
The current mono phase 3 trial is an investigational trial that the FDA declined a BLA filing for. Most likely the results being after 10 weeks. Which is why we need to start a new Phase 3. The new Phase 3 will sort things out with the CCR5 occupancy test so we don't have viral spikes in the first ten weeks.
Nader says he's going to push out the start date of the new mono trial. I think that's a strategic mistake. A lot of our R&D cost is associated with the current Phase 3 and extension. By starting the new trial and doing a slow ramp up of patient induction and ending the old trial we can reduce monthly R&D expense. It's best to start the new trial after approval in HIV so patients in our current trial can have uninterrupted access to leronlimab.
Nader says he's going to push out the start date of the new mono trial. I think that's a strategic mistake. A lot of our R&D cost is associated with the current Phase 3 and extension. By starting the new trial and doing a slow ramp up of patient induction and ending the old trial we can reduce monthly R&D expense. It's best to start the new trial after approval in HIV so patients in our current trial can have uninterrupted access to leronlimab.
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