Tuesday, February 18, 2014 6:21:56 PM
You have been here throughout repeated discussions about them having to delay the data gathering phase of the toxicology testing to make more drugs
AND how that was because the toxicology was so low that much larger amounts of drugs would be needed because the FDA requires testing to the point of toxicity or to the maximum feasible dose if there is NO toxicity below that
AND about how good that was because it meant that the odds of success in a clinical trial were much greater AND all the reasons why that was so
AND about how they'd have to wait for the new lab to produce that much larger amount of drugs
AND about how the low toxicity meant that the probability of an early approval and many other FDA expediting measures would mean that the short delay for the higher amount of drugs to b e made in the new labs would be more than compensated for by the time savings of all that
And much much more.
All of that repeated many times while you were here and yet you apparently have no idea why they are not yet in the final stage (data gathering) of tox (while the EARLY stage: dose ranging has already been completed! Did you miss THAT too?)
It does raise questions.
AND how that was because the toxicology was so low that much larger amounts of drugs would be needed because the FDA requires testing to the point of toxicity or to the maximum feasible dose if there is NO toxicity below that
AND about how good that was because it meant that the odds of success in a clinical trial were much greater AND all the reasons why that was so
AND about how they'd have to wait for the new lab to produce that much larger amount of drugs
AND about how the low toxicity meant that the probability of an early approval and many other FDA expediting measures would mean that the short delay for the higher amount of drugs to b e made in the new labs would be more than compensated for by the time savings of all that
And much much more.
All of that repeated many times while you were here and yet you apparently have no idea why they are not yet in the final stage (data gathering) of tox (while the EARLY stage: dose ranging has already been completed! Did you miss THAT too?)
It does raise questions.
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