Not sure on the why FDA hasn't given the green lig
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(Total Views: 569)
Posted On: 04/07/2021 5:33:19 PM
Not sure on the why FDA hasn't given the green light, but I know writing a trial protocol is not that straight forward, especially when one needs to figure out and negotiate the best endpoints and such with FDA. With finalizing the prior trial data analysis and trying to pick the best population and endpoints, I think they are moving relatively quickly.
I did hear on the call a Q about when CD16 will start, and I thought I heard NP answer hopefully next week for approval to proceed. I thought I did hear him say the endpoint would be proportion off of ventilation and alive at 28 days. I thought I heard him say a lot of the trial could be in Brazil, and I believe he said that they are checking with Brazilian regulators to make sure the trial meets their demands as well. I heard someone ask about risk-benefit analysis of running the trial, and didn't hear a great answer, other than results so far in critical were great, and with Covid raging some places (Brazil), it could be a fairly quick trial (relatively speaking).
There is a LOT up in the air and a LOT going on at CYDY! Hopefully they are able to manage everything, given they are not a huge company, and that MR is gone.
I was very glad to hear they still plan on submitting HIV combo BLA "hopefully next month," for 700 mg in US and abroad same dosing. It sounds like MR never quite fit in with the rest. He was a relatively big name with good experience, but I'm not sure what he was doing for us besides being assigned the BLA. It sounds like Recknor sort of just took over, and perhaps that is why MR is gone. I will miss MR, mainly because everyone gets so excited saying his first name.
Good to hear pre-BTD meeting soon for cancer basket.
Again, lots of balls in the air being juggled, and hopefully one will go through the hoop / hit the target / score a goal pretty soon. They are going balls to the wall (yeah, I know combined some balls metaphors there).
I did hear on the call a Q about when CD16 will start, and I thought I heard NP answer hopefully next week for approval to proceed. I thought I did hear him say the endpoint would be proportion off of ventilation and alive at 28 days. I thought I heard him say a lot of the trial could be in Brazil, and I believe he said that they are checking with Brazilian regulators to make sure the trial meets their demands as well. I heard someone ask about risk-benefit analysis of running the trial, and didn't hear a great answer, other than results so far in critical were great, and with Covid raging some places (Brazil), it could be a fairly quick trial (relatively speaking).
There is a LOT up in the air and a LOT going on at CYDY! Hopefully they are able to manage everything, given they are not a huge company, and that MR is gone.
I was very glad to hear they still plan on submitting HIV combo BLA "hopefully next month," for 700 mg in US and abroad same dosing. It sounds like MR never quite fit in with the rest. He was a relatively big name with good experience, but I'm not sure what he was doing for us besides being assigned the BLA. It sounds like Recknor sort of just took over, and perhaps that is why MR is gone. I will miss MR, mainly because everyone gets so excited saying his first name.
Good to hear pre-BTD meeting soon for cancer basket.
Again, lots of balls in the air being juggled, and hopefully one will go through the hoop / hit the target / score a goal pretty soon. They are going balls to the wall (yeah, I know combined some balls metaphors there).
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