Don't overlook the DSMC recommendation that the co
Post# of 154453
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Posted On: 12/15/2021 3:37:58 PM
Don't overlook the DSMC recommendation that the company look at the 42 day data, as well, beyond merely the 28 in the protocol, if I am recalling correctly.
All this would have done would make the data worse and string out the study longer wasting more time and money for the company. Fortunately, the company disregarded this "suggestion," if I remember correctly.
Recall there were only injections at days 0 and 7.
This "suggestion" has all the feelings of a set-up.
IMHO, if they did their job, they should have said, change the primary data point to 14 days, not let's look at 42 days, too.
Also, my memory was before the study started, they were planning to use 14 days as the primary, but someone (don't recall who or if they even said who) recommended that they change it to 28 days, which the company complied. This might have worked if they added day 14 and 21 injections, but without the additional injections being suggested, too, IMHO, you have to question the competence, qualifications and motives of those that first suggested a 28 day primary (for a day 0 and 7 injection study), instead of a 14 day primary (for that day 0 and 7 injection study), and then of those that suggested during the trial to look at day 42, as well.
There is a lot of circumstantial evidence in all of this. Maybe one day someone will get to the bottom of this. But, for now, the company needs to get an approval somewhere for something.
All this would have done would make the data worse and string out the study longer wasting more time and money for the company. Fortunately, the company disregarded this "suggestion," if I remember correctly.
Recall there were only injections at days 0 and 7.
This "suggestion" has all the feelings of a set-up.
IMHO, if they did their job, they should have said, change the primary data point to 14 days, not let's look at 42 days, too.
Also, my memory was before the study started, they were planning to use 14 days as the primary, but someone (don't recall who or if they even said who) recommended that they change it to 28 days, which the company complied. This might have worked if they added day 14 and 21 injections, but without the additional injections being suggested, too, IMHO, you have to question the competence, qualifications and motives of those that first suggested a 28 day primary (for a day 0 and 7 injection study), instead of a 14 day primary (for that day 0 and 7 injection study), and then of those that suggested during the trial to look at day 42, as well.
There is a lot of circumstantial evidence in all of this. Maybe one day someone will get to the bottom of this. But, for now, the company needs to get an approval somewhere for something.
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