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Posted On: 10/20/2020 11:14:26 PM
Post# of 148878
Yes the bit about continue and you'll hit your endpoint was nice. And the OWS answer in the conference call later in the day was interesting as well.
The big questions:
Safety? IMO yes based on an abundance of data from the CD12 interim look & earlier safety review, from the completed CD10, from the compassionate use patients, and from the HIV trials data.
Efficacy in Covid-19? IMO yes from the CD12 enrollment midpoint review where the committee requests another data review at 75% enrollment rather than simply waiting for 100% enrollment. IMO it's close to robust enough data now and the request for a look at the 75% enrollment means that the committee thinks that at 75% enrollment, there will be enough cushion of success in the data at that point to more than satisfy the regulators.
JMO.
The big questions:
Safety? IMO yes based on an abundance of data from the CD12 interim look & earlier safety review, from the completed CD10, from the compassionate use patients, and from the HIV trials data.
Efficacy in Covid-19? IMO yes from the CD12 enrollment midpoint review where the committee requests another data review at 75% enrollment rather than simply waiting for 100% enrollment. IMO it's close to robust enough data now and the request for a look at the 75% enrollment means that the committee thinks that at 75% enrollment, there will be enough cushion of success in the data at that point to more than satisfy the regulators.
JMO.
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