(Total Views: 562)
Posted On: 09/29/2025 11:44:20 AM
Post# of 157484
But Ohm , Dr Jay tried , this is all our speculation ..
And possibly he did , why not to tell the investors something , why in the last 2-3 years everything is a secret..
Ohm I tell you my opinion..
First , they knew about unusual results in TNBC last year already , this is why they started 3 preclinical studies in mTNBC .
Why not to cancel then CRC , and just continue with TNBC and ICs , even if at the end of last December we didn't know about PD-L1 , we knew we have something in TNBC with ICIs , and trial could be design.
But ok, we continue with CRC , but hoping for the same results with PD-L1 , it is impossible for me to accept that FDA will not approve this.
Someone posted they want to see how LL will work on it own , this cant be it , as design of CRC will need to be different..
We will need 50% of patients on
chemo and placebo,
and 50% patients on chemo and LL
So in this design we can only prove what % of the patients will develop higher PD-L1, and this is very good , and we probably will have 5-10 % above SOC with LL , but this will give us only phase 3..
With designing of the protocol , enrolling , and then a study , we will have results the soonest in 5 years.
If we add ICIs during our present trial , and if we show results , not 5-10 % , but 88% as in TNBC , we have a chance for conditional approval with phase 4.
Dramatic difference for the patients and our company.
All IMO.
And possibly he did , why not to tell the investors something , why in the last 2-3 years everything is a secret..
Ohm I tell you my opinion..
First , they knew about unusual results in TNBC last year already , this is why they started 3 preclinical studies in mTNBC .
Why not to cancel then CRC , and just continue with TNBC and ICs , even if at the end of last December we didn't know about PD-L1 , we knew we have something in TNBC with ICIs , and trial could be design.
But ok, we continue with CRC , but hoping for the same results with PD-L1 , it is impossible for me to accept that FDA will not approve this.
Someone posted they want to see how LL will work on it own , this cant be it , as design of CRC will need to be different..
We will need 50% of patients on
chemo and placebo,
and 50% patients on chemo and LL
So in this design we can only prove what % of the patients will develop higher PD-L1, and this is very good , and we probably will have 5-10 % above SOC with LL , but this will give us only phase 3..
With designing of the protocol , enrolling , and then a study , we will have results the soonest in 5 years.
If we add ICIs during our present trial , and if we show results , not 5-10 % , but 88% as in TNBC , we have a chance for conditional approval with phase 4.
Dramatic difference for the patients and our company.
All IMO.

