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Posted On: 12/10/2020 5:28:11 PM
Post# of 148899
Productive call, albeit with a fair amount of rehashing.
What really burned me was Dr.NP's "Right to Try" story about friend's family member who needed 3 doses to turn the corner and survive.
I will never forgive the FDA for limiting our CD12 trial to only 2 doses -- when we repeatedly asked for 3 or more doses.
How many more treatment arm patients in the CD12 would have survived with an additional one or two doses?
And assuming that trial has a favorable outcome, and the media starts reporting on our trial efficacy -- how much better would our story have been in terms of survival rates, if we had just been able to administer more than 2 doses?
This makes me very angry.
Lastly, regarding the LH protocol, I will only say that I am concerned that we are repeating the M/M CD10 mistake of having a subjective primary endpoint of fatigue. That's not how Dr.BP is handling it, and more than anyone else, he knows what he's doing.
What really burned me was Dr.NP's "Right to Try" story about friend's family member who needed 3 doses to turn the corner and survive.
I will never forgive the FDA for limiting our CD12 trial to only 2 doses -- when we repeatedly asked for 3 or more doses.
How many more treatment arm patients in the CD12 would have survived with an additional one or two doses?
And assuming that trial has a favorable outcome, and the media starts reporting on our trial efficacy -- how much better would our story have been in terms of survival rates, if we had just been able to administer more than 2 doses?
This makes me very angry.
Lastly, regarding the LH protocol, I will only say that I am concerned that we are repeating the M/M CD10 mistake of having a subjective primary endpoint of fatigue. That's not how Dr.BP is handling it, and more than anyone else, he knows what he's doing.
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