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Posted On: 10/10/2019 5:10:32 PM
Post# of 149805
Misiu, Trding, others,
Have been busy but reading with "fruition" all your very informative posts.Thank you very much for your continuous sharing of knowledge and comments.
I agree, my belief is that FDA required the 700 mg safety data as an up-limit of potential dosage in view of the possibility of occupancy-dependent dosage. Of course, as well for the possibility of improving over the already satisfactory 525 mg data. In a way, CYDY has been victim of its own success; as there was improvement from 350mg (with 525), the question was: will a higher dose improve even more?. And here it comes 700 mg …
Also, the mono will have already this valuable information (safety-efficacy) from combo and the process will be facilitated.
In a positive note: don't forget that FDA said: "adamantly want to approve". We are basically de-risked provided we can survive the financing issue for few more months (maybe weeks).
GLTUA
Have been busy but reading with "fruition" all your very informative posts.Thank you very much for your continuous sharing of knowledge and comments.
I agree, my belief is that FDA required the 700 mg safety data as an up-limit of potential dosage in view of the possibility of occupancy-dependent dosage. Of course, as well for the possibility of improving over the already satisfactory 525 mg data. In a way, CYDY has been victim of its own success; as there was improvement from 350mg (with 525), the question was: will a higher dose improve even more?. And here it comes 700 mg …
Also, the mono will have already this valuable information (safety-efficacy) from combo and the process will be facilitated.
In a positive note: don't forget that FDA said: "adamantly want to approve". We are basically de-risked provided we can survive the financing issue for few more months (maybe weeks).
GLTUA
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