(Total Views: 932)
Posted On: 03/24/2021 4:02:07 PM
Post# of 153895
Z_Smith , someone texted me your post and asked to comment..
I hope you don't mind if I do...
We had a very good results in our combo with 350 mg , at efficacy of 81% and not one serious side effect, when other 2 approved drugs were and are 45% efficacy with Maraviroc , and severe side effects , and 43% with every 2 weeks IV treatment with Ibalizumab..
At the same time we started to do higher dose with monotherapy , 525 mg and 700 mg with better results then 350 mg...
And of course FDA wanted to help us , so they asked to do some more patients for safety in mono with 525 mg and 700 mg and they will choose what dose to approve for our combo , since in their opinion we could do better then 81 %...
" you have a great results with 350mg but we see you much better with a higher dose.." .......was said by FDA according to our company..
After FDA delayed us with this for about 9-10 months they chose 700 mg..
And nothing but delays continue.. this was nothing to do with ROT ,
Our study for combo with 350 mg with 81% efficacy was finished in February 2018, and IMO we should be approve then with these results...
And they asked for ROT sometimes October of 2020.
Why , to ask for it few years after study finished no one will ever know, is my opinion...
All imo.
I hope you don't mind if I do...
We had a very good results in our combo with 350 mg , at efficacy of 81% and not one serious side effect, when other 2 approved drugs were and are 45% efficacy with Maraviroc , and severe side effects , and 43% with every 2 weeks IV treatment with Ibalizumab..
At the same time we started to do higher dose with monotherapy , 525 mg and 700 mg with better results then 350 mg...
And of course FDA wanted to help us , so they asked to do some more patients for safety in mono with 525 mg and 700 mg and they will choose what dose to approve for our combo , since in their opinion we could do better then 81 %...
" you have a great results with 350mg but we see you much better with a higher dose.." .......was said by FDA according to our company..
After FDA delayed us with this for about 9-10 months they chose 700 mg..
And nothing but delays continue.. this was nothing to do with ROT ,
Our study for combo with 350 mg with 81% efficacy was finished in February 2018, and IMO we should be approve then with these results...
And they asked for ROT sometimes October of 2020.
Why , to ask for it few years after study finished no one will ever know, is my opinion...
All imo.
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