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Posted On: 08/26/2019 11:20:44 AM
Post# of 149015
This AM I asked Marek if he can tell us when we should expect results of first CTC of our patient to be public.
He just answered me that they just discussed that with Dr NP , and apparently FDA do not agree to make public one result of one patient during any study...
And then he added..
" More data , any data , is always better than no data . Thus , hopefully we can figure something out that satisfies the FDA and all of us, and our need for information .
But the key point to emphasize that no info DOES NOT mean negative results .
It just simply is driven by protocols of dealing with single patient data. "
As to how long it takes for CTC results to come back , he think not very long , since it is really simple test , but he will check with Dr NP and let me know....
Well , one thing is , for sure we don't want to do anything to upset FDA !!!!!
I am sure that all here will understand that...
He just answered me that they just discussed that with Dr NP , and apparently FDA do not agree to make public one result of one patient during any study...
And then he added..
" More data , any data , is always better than no data . Thus , hopefully we can figure something out that satisfies the FDA and all of us, and our need for information .
But the key point to emphasize that no info DOES NOT mean negative results .
It just simply is driven by protocols of dealing with single patient data. "
As to how long it takes for CTC results to come back , he think not very long , since it is really simple test , but he will check with Dr NP and let me know....
Well , one thing is , for sure we don't want to do anything to upset FDA !!!!!
I am sure that all here will understand that...
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