I hear all the views expressed here today about ti
Post# of 153880
(Total Views: 708)
Posted On: 07/15/2020 11:08:38 AM
I hear all the views expressed here today about timelines and HIV Duel and Covid. From a more positive outlook from me being and optimist like I am.
We have a rolling review with our HIV Duel therapy application submission correct? Then the FDA should be continuing to review our BLA as we gather the requested additional information, correct? They don’t just put it on the back shelf and say when you have it all we will review it. As for the timeline for the PDUFA date. It may not be as long as one would think if they are reviewing the information they have currently as they await the additional information to file the BLA. Why would they just start over with a extended 6 month date when they have this big head start?
Granted FDA workload may be heavy during this pandemic. I am assuming they were assigned a team of people to review their application because they know as well as we know that the safety is the most important issue at hand for a covid approval. I believe in good people in every group and the FDA will also have good people that would love to be able to prove our little molecule as the best thing for Covid if it has the data to support it. I believe that Dr. Patterson knows exactly how good the lab results are and the FDA can not overlook that.
Just think about being able to tell your children and grand children how when you worked for the FDA you were on this important review team that approved the drug that saved thousands and thousands of lives. That has to be motivation enough for most people just knowing mankind needs something to help stop this pandemic.
Or maybe I just live in a dream world? But it is nice to dream that people care. That people do the right thing for the good of all. Let’s just hope those people are the ones reviewing right now our BLA.
We have a rolling review with our HIV Duel therapy application submission correct? Then the FDA should be continuing to review our BLA as we gather the requested additional information, correct? They don’t just put it on the back shelf and say when you have it all we will review it. As for the timeline for the PDUFA date. It may not be as long as one would think if they are reviewing the information they have currently as they await the additional information to file the BLA. Why would they just start over with a extended 6 month date when they have this big head start?
Granted FDA workload may be heavy during this pandemic. I am assuming they were assigned a team of people to review their application because they know as well as we know that the safety is the most important issue at hand for a covid approval. I believe in good people in every group and the FDA will also have good people that would love to be able to prove our little molecule as the best thing for Covid if it has the data to support it. I believe that Dr. Patterson knows exactly how good the lab results are and the FDA can not overlook that.
Just think about being able to tell your children and grand children how when you worked for the FDA you were on this important review team that approved the drug that saved thousands and thousands of lives. That has to be motivation enough for most people just knowing mankind needs something to help stop this pandemic.
Or maybe I just live in a dream world? But it is nice to dream that people care. That people do the right thing for the good of all. Let’s just hope those people are the ones reviewing right now our BLA.
(3)
(0)