Someone correct me if I am wrong, but my understan
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Posted On: 02/06/2020 1:21:22 PM
Someone correct me if I am wrong, but my understanding is the trial is only 30 people, but this IND approval allows for as many expanded access patients that qualify outside of the trial.....i.e. out of other viable treatment options.
I view the 30 patient trial as positive (for example the TNBC trial alone was designed for 48 patients), as I expected it to be much larges given that it is across potentially 22 different solid tumor cancers (less than 1.5 patients per indiciation)......but they are looking at MOA and not individual cancer type. If this trial is already approved (which is my understanding as they can immediately begin enrollment, but others made some valid opposing views that it may not be open to inject them yet?) that hints to me that the FDA only requiring 30 patients as a massively positive sign.
Clarification of whether the trial is approved by the FDA during today's CC is something I would like to find out.
I view the 30 patient trial as positive (for example the TNBC trial alone was designed for 48 patients), as I expected it to be much larges given that it is across potentially 22 different solid tumor cancers (less than 1.5 patients per indiciation)......but they are looking at MOA and not individual cancer type. If this trial is already approved (which is my understanding as they can immediately begin enrollment, but others made some valid opposing views that it may not be open to inject them yet?) that hints to me that the FDA only requiring 30 patients as a massively positive sign.
Clarification of whether the trial is approved by the FDA during today's CC is something I would like to find out.
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