What is the difference between LH and CD10 from a
Post# of 155138
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Posted On: 04/08/2021 8:57:37 PM
What is the difference between LH and CD10 from a registrational perspective, p2, p2/3? I honestly dont know. I understand the concepts i feel, but there was strong opinion in august that we should have been able to get eua for m2m.
I understand its not a p3, but neither was CD10 and we never followed on with a p3 from CD10.
Dont we have end points we are searching for in LH? could we not conceivably hit some clear metric in LH that would justify EUA? It just seems to me (and always did) that 50 was way too small a number, especially when management said it would be easy to fill (and was). Why not enroll 100 or 150, it would only take another couple weeks most likely and would give us oodles more data. But now with 50 people we will be have half the number we are touting in CD12 for 14 day mortality. We could have easily doubled the size and achieved the same power and opportunity.
I understand its not a p3, but neither was CD10 and we never followed on with a p3 from CD10.
Dont we have end points we are searching for in LH? could we not conceivably hit some clear metric in LH that would justify EUA? It just seems to me (and always did) that 50 was way too small a number, especially when management said it would be easy to fill (and was). Why not enroll 100 or 150, it would only take another couple weeks most likely and would give us oodles more data. But now with 50 people we will be have half the number we are touting in CD12 for 14 day mortality. We could have easily doubled the size and achieved the same power and opportunity.
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