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Re: A deleted message

Friday, 06/18/2021 11:33:49 AM

Friday, June 18, 2021 11:33:49 AM

Post# of 233271
WOW Jaylimab , what a great post.. I agree with your every word here.

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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