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Posted On: 09/11/2020 10:38:14 PM
Post# of 154115
very persuasive FBcoach but I think everything has been rolled into CD12.
If the FDA was going to disposition the mild/moderate separately from the severe/critical the FDA would have done so already.
Because as you point out a mild/moderate phase 3 might enroll and conclude very quickly. The NEWS2 primary endpoint for a potential mild/moderate phase 3 is already set up. Mild/moderate phase 3 is readyd to go.
But at this point the FDA has delayed a response to the mild/moderate sufficiently that it hardly makes sense to disposition mild/moderate when the severe/critical data collection stops in 11 days.
Once the Sept 22 deadline hits, it will overwhelm everything else.
The severe/critical primary endpoint is so trivial to evaluate that it could be availble on Sept 23.
Its not going to take weeks to evaluate the primary endpoint. If it takes two weeks to release the primary endpoint, that's because the safet committe will say "continue the trial to its 390 patient endpoint", and a mild/moderate phase 3 will be conducted concurrently with the second half of severe/critical.
If the FDA has waited this long to disposition CD10, I think they will wait 11 more days.
But what do I know? Perhaps nothing.
When they hold the Wednesday conference call next week there are only six days until full stop on CD12 data collection.
If the FDA was going to disposition the mild/moderate separately from the severe/critical the FDA would have done so already.
Because as you point out a mild/moderate phase 3 might enroll and conclude very quickly. The NEWS2 primary endpoint for a potential mild/moderate phase 3 is already set up. Mild/moderate phase 3 is readyd to go.
But at this point the FDA has delayed a response to the mild/moderate sufficiently that it hardly makes sense to disposition mild/moderate when the severe/critical data collection stops in 11 days.
Once the Sept 22 deadline hits, it will overwhelm everything else.
The severe/critical primary endpoint is so trivial to evaluate that it could be availble on Sept 23.
Its not going to take weeks to evaluate the primary endpoint. If it takes two weeks to release the primary endpoint, that's because the safet committe will say "continue the trial to its 390 patient endpoint", and a mild/moderate phase 3 will be conducted concurrently with the second half of severe/critical.
If the FDA has waited this long to disposition CD10, I think they will wait 11 more days.
But what do I know? Perhaps nothing.
When they hold the Wednesday conference call next week there are only six days until full stop on CD12 data collection.
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