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Minimally, the PR will announce approval for the n

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Post# of 72444
Posted On: 12/11/2012 11:30:46 PM
Posted By: BigKahuna
Re: biomanbaba #3855

Minimally, the PR will announce approval for the next cohort, this will include confirming a doubling of the dose. Depending on what might be ready it can optimally include approval of treatment continuation for the first cohort based on benefit, might even summarize what that benefit would be, whether or not there was a change in tumor marker in the blood samples, summary of qualitative assessment of the cohort, and whether or not they will be able to play the piano. PK/PD, qPCR, p23, RECIST assessment probably will not be ready until after the holidays.



Here's the thing, either the cohorts each show some observable improvement, or they don't. Other than that, all the numbers mean nothing except for the final direct measure of tumors. We already know Kevetrin will be well-tolerated at therapeutic levels. Recall that mice had tumors that responded to low doses and had maximum response very near the MTD. No reason to think any of that will be different other than where the human MTD falls.



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