Interesting that they are seeking approval of the
Post# of 155498
(Total Views: 894)
Posted On: 08/07/2020 1:24:27 AM
Interesting that they are seeking approval of the 350mg dose (which was the actual trial dosage), as opposed to 700mg dose pushed by the FDA -- which subsequently issued the RTF demanding the integrated assessment of the Mono CD03 at 700mg.
Also, regarding the stated 173 enrolled as of August 6, we are actually picking up some speed. If this new enrollment rate remains constant:
- We had 165 enrolled on August 2 -- and 173 enrolled on August 6.
- That's 8 subjects in 4 days.
- That's 2 subjects enrolled per day.
- With 22 subjects left to go, we might be able to hit 195 in 11 days.
- That puts us at full interim enrollment on August 17.
- Assuming the 195th patient is treated the same day of enrollment ...
- Day 28 would be September 3.
- Three weeks for data analysis puts us at September 24.
Also, regarding the stated 173 enrolled as of August 6, we are actually picking up some speed. If this new enrollment rate remains constant:
- We had 165 enrolled on August 2 -- and 173 enrolled on August 6.
- That's 8 subjects in 4 days.
- That's 2 subjects enrolled per day.
- With 22 subjects left to go, we might be able to hit 195 in 11 days.
- That puts us at full interim enrollment on August 17.
- Assuming the 195th patient is treated the same day of enrollment ...
- Day 28 would be September 3.
- Three weeks for data analysis puts us at September 24.
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