Thursday, August 18, 2022 10:12:13 AM
"New Drug Applications (NDA) require certification that trial registration is up-to-date (IND sponsor must submit an FDA Form 3674 to their IND file)"
That seems to indicate that IPIX obviously must have their results posted for any drug/indication for which they hope to secure approval:
"In other words, sponsors cannot file for an NDA for a drug if all the trial registration data is not up-to-date." For THAT drug, correct?
Your use of the plural here is throwing me off:
"it's a sine qua non for future submissions that previous trials are reported on clinicaltrials.gov"
As long as the B-cv P2 results get posted then THAT requirement will have been met should an NDA for B-cv be submitted someday, right?
And a failure to pursue the review process to its end would mean that they couldn't meet that requirement, right?
Please dumb it down for me if you can. I don't want to miss whatever point it is that you're making, in case there is one above and beyond positive responses to the questions above.
It's morally wrong to allow a sucker to keep his money.
......W. C. Fields
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