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Whatsupp

04/09/17 6:30 PM

#3040 RE: XenaLives #3037


Whether you think it is likely has nothing to do with the fact that the FDA thinks it does.
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MinnieM

04/09/17 6:35 PM

#3041 RE: XenaLives #3037

FDA would take safety data into consideration even if the trials were unsuccessful for cancer. Was the drug shown to be relatively safe in the cancer studies?





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doingmybest

04/10/17 11:09 AM

#3076 RE: XenaLives #3037

Bryostatin has much more drug safety data than is typical at this stage of development. There is much value to the multi year safety profiles from the cancer trials, but, there can be specific signals that were not specified to seek out that were not looked for given the differences in time and indications studied. But, overall safety is in very good shape given the number and duration of study, realizing all side effects are looked for in general. You are focused on the possibility of long term growth factor effect, and, that is something that is most likely already being studied. Bear in mind the dosage is so much lower now than in cancer trials that there is even more reason not to be deeply concerned, though, there are always unforeseen things that occur during development particularly when done by small startups (NTRP and AVXL) who do not have the resources to perform the depth of supporting studies nor of chemical and biological characterizations as BP does.