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Re: Lykiri post# 185297

Monday, 08/06/2018 6:46:00 PM

Monday, August 06, 2018 6:46:00 PM

Post# of 732222
I believe I understand what you're saying, but how are patients treated who cross over to our drug. Do the K-M plots have a way of saying for instance 14 months after surgery a patient progressed, but crossed over and is still alive, or has passed after crossing over.

I'm of the belief that the FDA needs to recognize that any improvement, regardless of how small, should be approved to see if in combinations not tried during trials it may do substantially better. Quality of life should also be considered and I have no idea if those taking our drug are having a better, or worse quality of life. If it's better, that certainly should be a consideration, if worse, it works against us. It may be a judgement call but the clinicians should certainly be able to judge that as they learn which patients did, or didn't receive the drug from the beginning.

Gary
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