SteelPharm -I am sorry but I can’t answer you on
Post# of 154378
(Total Views: 295)
Posted On: 05/06/2019 9:44:51 PM
SteelPharm -I am sorry but I can’t answer you on the other board , there are no more investors there any longer , just a manipulators ... imo
I am so sorry that I made a post today .,,
This is my opinion ...
I think they believed until very recent that 700 mg is the dose ., this is why on interview April 15 dr NP said , this or next week we be submitting protocols for pivotal mono .
But they also continue studies with 525 , and good for FDA ,as you said , we always even with safe medicine want a lowest dose with best results , and FDA said after evaluating , wait , we don’t need more than 525 looking at your results with longer overlap .,.here I am really impressed with FDA !!!
So here we are .,,I believe that 700 mg dose we done with !!!
We are in 525 and we have more than 100 patients for longer than 24 weeks by now , so let’s finish with BLA soon ..
And let’s progress !!!!
I like from May 2 , starting at about 10:20 Dr NP saying
“ I am telling you today , we no longer need more data from 700 mg “‘
It was great ..
And as always imo only ...
I am so sorry that I made a post today .,,
This is my opinion ...
I think they believed until very recent that 700 mg is the dose ., this is why on interview April 15 dr NP said , this or next week we be submitting protocols for pivotal mono .
But they also continue studies with 525 , and good for FDA ,as you said , we always even with safe medicine want a lowest dose with best results , and FDA said after evaluating , wait , we don’t need more than 525 looking at your results with longer overlap .,.here I am really impressed with FDA !!!
So here we are .,,I believe that 700 mg dose we done with !!!
We are in 525 and we have more than 100 patients for longer than 24 weeks by now , so let’s finish with BLA soon ..
And let’s progress !!!!
I like from May 2 , starting at about 10:20 Dr NP saying
“ I am telling you today , we no longer need more data from 700 mg “‘
It was great ..
And as always imo only ...
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