Copied from Yahoo board. Makes sense. >>> Thou
Post# of 154089
(Total Views: 934)
Posted On: 11/09/2020 7:05:13 PM
Copied from Yahoo board. Makes sense.
>>>
Thoughtful Investing 1 hour ago:
Just listened to Pfizer's CEO on CNN. He did not overstate his case. Said they don't know how long the immunity will last and have to do 2 years of follow up to find out. But one thing he said that was very interesting was concerning his experience with the DSMC.
The interviewer raised the issue of Pfizer waited till the Sunday after the election to do the interim look at the results. Why not look before? The CEO said it was out of his hands. This was decided by the DSMC. Unlike the leronlimab severe/critical trial, the Pfizer trial was of heathy people and the DSMC needed to see to see enough sick people to draw a conclusion. The DSMC took a look in October and said there were not enough sick people to make a determination but that they wanted to do an interim look when there were at least 64 sick people who became ill. The DSMC projected that based on the infection rate, Sunday would be the time to look. Turned out they had more, 94 infected people. When they reviewed the results, they called the CEO and reported 90% protection rate. But the CEO has still not seen the unblinded data and they are continuing the study which they expect to conclude in late November. So clearly, the DSMC is driving the interim review schedule, not the company.
With Cytodyn, the DSMC looked at the 195 severe/critical Covid patient point and said they want to look again at 293 (they don't have to project anything since all the patients are sick). This request to Cytodyn indicated that the DSMC saw a trend at 195 that indicated that there was a good chance that at 293 patients, they would have sufficient information to show efficacy with statistical significance. Otherwise the DSMC would have stopped the trial.
This is not new news to longs but it is nice to see that Cytodyn is being treated in the same manner as Pfizer.
And I am expecting a similar good result for leronlimab.
>>>
Thoughtful Investing 1 hour ago:
Just listened to Pfizer's CEO on CNN. He did not overstate his case. Said they don't know how long the immunity will last and have to do 2 years of follow up to find out. But one thing he said that was very interesting was concerning his experience with the DSMC.
The interviewer raised the issue of Pfizer waited till the Sunday after the election to do the interim look at the results. Why not look before? The CEO said it was out of his hands. This was decided by the DSMC. Unlike the leronlimab severe/critical trial, the Pfizer trial was of heathy people and the DSMC needed to see to see enough sick people to draw a conclusion. The DSMC took a look in October and said there were not enough sick people to make a determination but that they wanted to do an interim look when there were at least 64 sick people who became ill. The DSMC projected that based on the infection rate, Sunday would be the time to look. Turned out they had more, 94 infected people. When they reviewed the results, they called the CEO and reported 90% protection rate. But the CEO has still not seen the unblinded data and they are continuing the study which they expect to conclude in late November. So clearly, the DSMC is driving the interim review schedule, not the company.
With Cytodyn, the DSMC looked at the 195 severe/critical Covid patient point and said they want to look again at 293 (they don't have to project anything since all the patients are sick). This request to Cytodyn indicated that the DSMC saw a trend at 195 that indicated that there was a good chance that at 293 patients, they would have sufficient information to show efficacy with statistical significance. Otherwise the DSMC would have stopped the trial.
This is not new news to longs but it is nice to see that Cytodyn is being treated in the same manner as Pfizer.
And I am expecting a similar good result for leronlimab.
(5)
(0)