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| Alias Born | 06/09/2020 |
Wednesday, April 26, 2023 8:16:47 AM
....that didn't change after bad data came out from the gold standard RCT trial, unlike DCVax
There's no "bad data".
FROM
The Use of External Controls in FDA Regulatory Decision Making
13 authors from FDA, including Pazdur, published the article "External control arms in oncology: current use and future directions" in Annals of Oncology
External control arms in oncology: current use and future directions
Endorsed by Larry Smith as a huge positive
https://smithonstocks.com/northwest-biotherapeutics-fda-statement-regarding-use-of-external-controls-in-clinical-trials-is-a-huge-positive/
Then came FDA's own guidance on ECA's here in 2023
https://www.fda.gov/media/164960/download
And waddayaknow!
Then MHRA in the UK endorsed historical controls, in the Pathway to a Cure report announced a month ago, in which british politicians from the All-Party Parliamentary Group on Brain Tumours, SPECIFICALLY pointed to DCVax-L
And last but not least we have Linda Liau being interviewed by JAMA saying at 7:59:
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
There are no bad data. There are just ethical concerns and all signs saying
YES .... MHRA and FDA will approve.
Which is why MHRA in every way have been preparing for exactly that!
Info which can be read about here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171701145
There's no "bad data".
45 approvals id'ed where FDA accepted ext. control data in benefit/risk assessment; doing so for many reasons incl. rare nature of the disease, ethical concerns wrt use ofplacebo or no-treatment arm, seriousness of condition, and unmet medical need
FROM
The Use of External Controls in FDA Regulatory Decision Making
13 authors from FDA, including Pazdur, published the article "External control arms in oncology: current use and future directions" in Annals of Oncology
External control arms in oncology: current use and future directions
Endorsed by Larry Smith as a huge positive
https://smithonstocks.com/northwest-biotherapeutics-fda-statement-regarding-use-of-external-controls-in-clinical-trials-is-a-huge-positive/
Then came FDA's own guidance on ECA's here in 2023
Considerations for the Design
and Conduct of Externally
Controlled Trials for Drug and
Biological Products
Guidance for Industry
https://www.fda.gov/media/164960/download
And waddayaknow!
Then MHRA in the UK endorsed historical controls, in the Pathway to a Cure report announced a month ago, in which british politicians from the All-Party Parliamentary Group on Brain Tumours, SPECIFICALLY pointed to DCVax-L
And last but not least we have Linda Liau being interviewed by JAMA saying at 7:59:
"There was a crossover arm designed into the trial and that was actually mandated by the FDA".
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
There are no bad data. There are just ethical concerns and all signs saying
YES .... MHRA and FDA will approve.
Which is why MHRA in every way have been preparing for exactly that!
Info which can be read about here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171701145
Bullish
