AI
Thursday, July 03, 2025 7:56:28 PM
Hopeforthefuture3, this is very common misconception, and often repeated Bear narrative.
Regulators (FDA, MHRA, EMA, etc.) only ask for or require patient-level data when an external control arm (ECA) is based upon real world data (RWD) or real world evidence (RWE).:
https://www.fda.gov/media/171667/download
As you may know, NWBio used an External Control Arm (ECA) to analyze and review the DCVax-L Phase III clinical trial results, but they did not use any RWD or RWE.
Instead, NWBio used pooled control group data from other concurrent and contemporaneous, peer-reviewed and published, randomized control trials (RCTs), to build its ECA.
All of the INDs for these RCTs were reviewed and approved by each of the regulators (FDA, EMA, MHRA, etc,) in the countries where these trials were conducted, and these regulators have access to all of the patient-level data, and the right to ask each Sponsor to provide all of these patient-level data:
Regulators (FDA, MHRA, EMA, etc.) only ask for or require patient-level data when an external control arm (ECA) is based upon real world data (RWD) or real world evidence (RWE).:
https://www.fda.gov/media/171667/download
As you may know, NWBio used an External Control Arm (ECA) to analyze and review the DCVax-L Phase III clinical trial results, but they did not use any RWD or RWE.
Instead, NWBio used pooled control group data from other concurrent and contemporaneous, peer-reviewed and published, randomized control trials (RCTs), to build its ECA.
All of the INDs for these RCTs were reviewed and approved by each of the regulators (FDA, EMA, MHRA, etc,) in the countries where these trials were conducted, and these regulators have access to all of the patient-level data, and the right to ask each Sponsor to provide all of these patient-level data:
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!!!
