(Total Views: 475)
Posted On: 04/08/2020 8:17:17 AM
Post# of 155128
Re: Bobbythebus #26251
The 342 was definitely an error
In the proactive video, Nader explained that the FDA changed two things in their review period post protocol submission
1) patient count from 342 to 390
2) primary endpoint from survival at 14 to survival at 28 days with secondary endpoint of survival at 14 days.
The Novant PR updated item 2 but not item 1
This is not on Nader but the person responsible to PRs whoever that is.
If I can notice the problem in one second when reading the PR, the person responsible for communications should be able to do that as well.
I have worked in pharma and diagnostics for more that 28 years and i can tell you that the FDA is a sticker for detail so you need great attention to detail when working with them so this needs to improve if we want to be wildly successful.
Finally, these errors just leads to distractions for Nader to try to clean up and correct since he is the face of the company and this draws his attention from more important things.
In the proactive video, Nader explained that the FDA changed two things in their review period post protocol submission
1) patient count from 342 to 390
2) primary endpoint from survival at 14 to survival at 28 days with secondary endpoint of survival at 14 days.
The Novant PR updated item 2 but not item 1
This is not on Nader but the person responsible to PRs whoever that is.
If I can notice the problem in one second when reading the PR, the person responsible for communications should be able to do that as well.
I have worked in pharma and diagnostics for more that 28 years and i can tell you that the FDA is a sticker for detail so you need great attention to detail when working with them so this needs to improve if we want to be wildly successful.
Finally, these errors just leads to distractions for Nader to try to clean up and correct since he is the face of the company and this draws his attention from more important things.
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