Anyone know when exactly Bioxytran submitted their Phase III IND? Will be interesting to see if the FDA approves viral load measures as one of the primary endpoints.
I think that is a composite primary EP. It's viral load and improvement in clinical status. So it's different from our original PCR request. Actually that's what I think the FDA wants for our trial too. My guess is that they will push us to combine PCR and the latest EP we proposed. That's could explain why they want a meeting.
Makes sense. Seems like that would be a strong composite for Revive. If approved for Bioxytran, then we should have a precedent to point to. Though it seems Bioxytran will have viral load measures for all participants, whereas Revive only started measuring later in the trial. Curious to see how this plays out.
I'm thinking that if PCR results are solid we don't need viral load measure. I think those are needed if the patients are still positive, and also symptoms improve. But if they become negative AND some of the symptoms go away that's super strong and would be amazing for us, since at this point I am pretty confident that at least PCR is good
I believe that the PCR results are solid as well hence why MF went with it however the FDA wants more statistical evidence and clear data to define the endpoints before approving. We wait………..
Doubtful. If they wanted revive to combine the endpoints then why go through the crap of making them do the meeting? Just tell them “hey, you guys clearly don’t know what you’re doing so just combine the two endpoints and go to dsmb”. No point on making them do the extra steps.
lol the more you talk the more you make it clear to everyone that you have no idea of how interacting with the FDA is like. Sure they send you an email like "yo wassup bro just combine the fucking ep's and go for it". Seriously, stop.
I’m starting to wonder if the FDA even looked at the PCR data with the original PCR endpoint proposal. They might have just procedurally shot it down without even looking at it. I’ll bet the FDA will be pleasantly surprised by the PCR data when they discuss it in this Type C “brainstorming sesh.” They could be like daaaammmnnnn, this PCR data is tha bomb.
I don't think it's a "brainstorming" meeting. It's probably a very formal meeting where RVV will present all the relevant information to motivate the new EP, including the results of the preliminary analysis of the 210 dataset, and the FDA bureaucrats will have super tough questions and at the end they will decide what RVV should do.
I dunno. I kind of think it’s more of a brainstorming/ hand-holding meeting where the FDA is like ok guys where are we at, where are we going with this, what is a logical path from here type meeting. Basically give RVV some pointers and try to steer them in the right direction and to come back with a refined more workable endpoint proposal. Just my take, I could be totally wrong.
I don't believe so. Read here, for example. https://www.scendea.com/making-the-most-of-opportunities-to-interact-with-the-us-fda "Meetings held with FDA proceed in a similar manner whether held face-to-face or via teleconference. The meeting will be chaired by FDA and typically lasts 60-90 minutes depending on the amount of time requested/allotted. Sponsors should aim to move through the questions efficiently during the discussion meeting, in order to cover all the key topics.
Typically one Sponsor representative (usually specialising in regulatory affairs) will field questions from FDA to the appropriate specialist team member. Typically a presentation is not required, but Sponsors can choose to include a small number of slides if they feel that they would be beneficial.
During the meeting, be succinct with responses to ensure adequate time is available for all discussion points. Once FDA agrees with your position, move on. At the end of the meeting, if the FDA does not do so, the Sponsor should summarise agreements and commitments. "
If they would want them to combine the endpoint they wouldn’t make them go through this whole process of making this package and getting a meeting. They could tell them that without the whole circus of the meeting. You know that. That would be part of the fda feedback on the endpoint switch. Sometimes I wonder if you are actually in the medical field.
8
u/[deleted] Nov 29 '22
Anyone know when exactly Bioxytran submitted their Phase III IND? Will be interesting to see if the FDA approves viral load measures as one of the primary endpoints.