On the 10/20 conference call Dr. JL said specifica
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Posted On: 01/19/2021 1:56:46 PM
On the 10/20 conference call Dr. JL said specifically that he was never thrilled with the 2 dose regiment for severe to critical. He thought all along that it should be 3 to 4 doses. The FDA said no and that we should go with 2 doses in each trial. In the spring he also said that he asked if we could administer the first dose via IV for the sickest of patients to get 100% occupancy sooner but again was denied by the FDA. If you recall, he also asked for 700mg to be the dose for cancer patients...again denied by the FDA and we are required to try 525mg before 700mg (even with the data from right to try patients who responded much better to 700mg).
From these examples I believe much of the blame should be put on the FDA. I am not sure why they aren't amenable to the dosing regiments requested but the company and their consultants (including Dr. Patterson) have clearly tried multiple times to get what they believe to be better dosing regiments approved.
My understanding is that there is a bit of a dance played between the sponsor and the FDA when it comes to trial design. We cannot look at a trial and say that everything that it contains was at the request of the company. There is certainly a give and take. While we can suggest things we would like at the end of the day we are at the mercy of the FDA and going against their recommendations is a very expensive gamble.
From these examples I believe much of the blame should be put on the FDA. I am not sure why they aren't amenable to the dosing regiments requested but the company and their consultants (including Dr. Patterson) have clearly tried multiple times to get what they believe to be better dosing regiments approved.
My understanding is that there is a bit of a dance played between the sponsor and the FDA when it comes to trial design. We cannot look at a trial and say that everything that it contains was at the request of the company. There is certainly a give and take. While we can suggest things we would like at the end of the day we are at the mercy of the FDA and going against their recommendations is a very expensive gamble.
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