InvestorsHub Logo
Followers 209
Posts 32128
Boards Moderated 1
Alias Born 06/30/2009

Re: sunspotter post# 392419

Thursday, 08/18/2022 10:12:13 AM

Thursday, August 18, 2022 10:12:13 AM

Post# of 402819
I'm afraid I don't understand how your answer relates to IPIX and your earlier comment.
"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

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent IPIX News