AI
Wednesday, September 06, 2023 2:36:20 PM
From my reading of the recent FDA guidance regarding the use of Real World Data (RWD) and Real World Evidence (RWE), it appeared to me that NWBio did not use either RWD or RWE in its DCVax-L Phase III clinical trial.
NWBio instead used contemporaneous external control arms (ECAs) from 7 other external randomized controlled trials (RCTs).
So, that prompted me to reach out directly to the FDA and ask them whether or not this would be considered RWD or RWE.
Take a look at my questions and the answers I received back from the FDA below:
As a result, the updated FDA guidance regarding RWD and RWE is not relevant to the DCVax-L Phase III trial. However, the guidance that is relevant, is the FDA guidance regarding the use of ECAs. Hopefully, the FDA will finalize the ECAs guidance soon:
https://www.fda.gov/media/164960/download
NWBio instead used contemporaneous external control arms (ECAs) from 7 other external randomized controlled trials (RCTs).
So, that prompted me to reach out directly to the FDA and ask them whether or not this would be considered RWD or RWE.
Take a look at my questions and the answers I received back from the FDA below:
As a result, the updated FDA guidance regarding RWD and RWE is not relevant to the DCVax-L Phase III trial. However, the guidance that is relevant, is the FDA guidance regarding the use of ECAs. Hopefully, the FDA will finalize the ECAs guidance soon:
https://www.fda.gov/media/164960/download
Bullish
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
TIME IS RUNNING OUT. THE CLOCK IS TICKING!!!
