1) On the 10/20 conference call Dr. Jay said specifically
1) On the 10/20 conference call Dr. Jay said specifically that 2 doses for s2c did not sit well with him. He said he asked he initially asked for 3 to 4 doses and the FDA said no. Dr. Yang also said as much in his paper. Dr. Seethamraju said 4 doses is what they used with the eind patients. The FDA also denied allowing us to go to 700mg for the cancer dosing despite our request to do so. What is their rationale? We have clinical data showing the benefits and we have great safety data at 700mg but we are continually told no. I would love to understand why. It honestly makes no sense to me.
2) Completely agree. Very happy to see the data but this should have been noted immediately. Given what Dr. Zaius posted there is no excuse for this not being known weeks ago.
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