NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

Little man, do some real research....

No matter what anybody says, NWBO cannot get approval until they run the pediatric trials. This is from the EMA - same rules apply MHRA

"All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver." If a waiver, trials must begin after submission.

NWBO submitted a SAP for pediatric trials, which has been accepted. But until they run - or start to collect enough data to make a case - they are dead in the water. No matter what, they have to run pediatric trials ..... Where is the news that says the company is busy making that happen?

The only information is buried in the Form 10-K
Page 25:
"During 2023 the Company also devoted substantial efforts to preparations for launching the two required pediatric clinical trials."
There is nothing mentioned about enrollment or how she is going to pay for the TWO trials. There is this little note..
Page 10
"Late-stage clinical trials, such as our Phase III clinical trial for GBM patients, are especially expensive, typically requiring tens or hundreds of millions of dollars, and take years to reach their outcomes."