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Posted On: 07/30/2019 5:14:31 PM
Post# of 149511
Re: BlueHorseshoe13 #5535
All this is impressive , and Dr ,Cristifanilli , believe that if first 5 treatment naive patients , will not be progressing as fast as patients without Leronlimab for about 4 months , they can apply for speedy approval , this is really good.
I am not surprised that good results with TNBC , medicine will be approved very soon , still it was nice to hear...
FDA will not allow those women to die if results will be good /better.
They approve if it shows 2 months on average longer life.
I don't know how long it will take them to get treatment naive patients , but in my experience should be less difficult that those patients who are treated with things not accepted by our protocol ...
And they have another way to go , they were talking today Expanded Access / Compassionate treatment...
Our first patient will be this patients , she is going threw tests now , so should be this/ next week if CCR5 positive ...
Apparently we can have approval by " prove of concept here "
I am not surprised that good results with TNBC , medicine will be approved very soon , still it was nice to hear...
FDA will not allow those women to die if results will be good /better.
They approve if it shows 2 months on average longer life.
I don't know how long it will take them to get treatment naive patients , but in my experience should be less difficult that those patients who are treated with things not accepted by our protocol ...
And they have another way to go , they were talking today Expanded Access / Compassionate treatment...
Our first patient will be this patients , she is going threw tests now , so should be this/ next week if CCR5 positive ...
Apparently we can have approval by " prove of concept here "
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