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Wednesday, April 24, 2024 12:34:07 PM
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."
Recent NWBO News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 09:06:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 08:30:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 02:42:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/30/2024 11:49:38 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
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