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Friday, June 18, 2021 11:33:49 AM
Thank you.
Just little about our phase 2 LH and results..
Phase 2 is like a discovery study..
It is done to see if drug has some chance to work in a particular disease.
So in USA success is if FDA allow the company to continue with phase 3.
If there is no sign of any efficacy , phase 3 is not done.
Now all the endpoints in phase 2 , not that important if one call them primary or secondary , because to design phase 3 all endpoints giving best results are pick , not important from primary or secondary endpoints , and those becoming a primary endpoints in phase 3 ..
So here if FDA will approve phase 3 , mean that results were good enough to investigate further .
What happened with our CD12 , it was 2b/3 study , mean combined phase 2 and 3 , and if FDA will not sabotage our study , we will meet the primary endpoint with 4 treatments , but they did.
Normally if this will only be phase 2 , even with cydy FDA couldn't refuse to have a 4 weeks treatments in phase 3 with our results .
These is a danger of doing together phase 2 and 3...of course if we be a BP , we be approved already a year ago , and many lives will be saved..
Someone posted a picture few days ago that our company taking registration for phase 3 in LH ..
If true , to me it means that phase 2 proved enough of efficacy and FDA agreed they be doing phase 3 , so it was a success.
All the best .
And IMO only..
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