Wednesday, August 12, 2015 1:39:46 PM
What you find hard to believe and what actually happens in clinical trials are two different things.
OK, let's focus on the 4.
Based on the PR, all 4 could have progressed, and at least 1 did. It said "were documented to have stable disease (by radiographic examinations) for 3 to 6 months while receiving Kevetrin."
The PR would have said "are currently SD" and not have given a window of time if they were all currently SD.
The ASCO abstract had to be submitted by Feb 3 2015 and at that time there were only two in the 9th cohort (including non-ovarian) that were not complete so by the time of the PR (August 7th), all in the 9th cohort had well over 3 months of treatment and possibly all had 6 months. That means someone progressed at only 3 months.
6% tumor reduction is still well away from a partial response (30% tumor shrinkage) which you are claiming will happen by upping the dose.
So by your assertion the guy in the 11th cohort at 750mg/m2 who is 3 months into treatment should at least have partial response by now. Where's the PR for that?
Leo is obviously providing the best data he currently has from the P1. And that was a period of SD. He is also choosing his wording very wisely. Maybe K is great for ovarian but from the PR, there are more questions than answers.
A simple chart would suffice, and just for the 9 he is PRing:
Cohort
current RECIST criteria
current treatment/dosage
I"m not short and I'm not bashing but I'm also not going to sit back because everyone on the board is hooraying incomplete data.
OK, let's focus on the 4.
Based on the PR, all 4 could have progressed, and at least 1 did. It said "were documented to have stable disease (by radiographic examinations) for 3 to 6 months while receiving Kevetrin."
The PR would have said "are currently SD" and not have given a window of time if they were all currently SD.
The ASCO abstract had to be submitted by Feb 3 2015 and at that time there were only two in the 9th cohort (including non-ovarian) that were not complete so by the time of the PR (August 7th), all in the 9th cohort had well over 3 months of treatment and possibly all had 6 months. That means someone progressed at only 3 months.
6% tumor reduction is still well away from a partial response (30% tumor shrinkage) which you are claiming will happen by upping the dose.
So by your assertion the guy in the 11th cohort at 750mg/m2 who is 3 months into treatment should at least have partial response by now. Where's the PR for that?
Leo is obviously providing the best data he currently has from the P1. And that was a period of SD. He is also choosing his wording very wisely. Maybe K is great for ovarian but from the PR, there are more questions than answers.
A simple chart would suffice, and just for the 9 he is PRing:
Cohort
current RECIST criteria
current treatment/dosage
I"m not short and I'm not bashing but I'm also not going to sit back because everyone on the board is hooraying incomplete data.
