Oncolytics Biotech Inc T.ONC

FDA ready to review novel cancer vaccine Platform Technology

[Noteable]

August 04, 2024 - The FDA's Peter Marks believes the FDA’s yet-to-be-formalized platform technology designation could be helpful.

The FDA recently issued draft guidance on the “advanced manufacturing technology” designation program, which was developed as part of the Food and Drug Omnibus Reform Act of 2022. The initiative is viewed as a step to facilitate the development of products based on novel technologies to improve the drug production process. The agency is still separately working on the specifics of the “platform” designation. The idea would be that products developed with the same platform technologies may enjoy streamlined reviews for subsequent advances.

The FDA has had the “platform” idea for some time. But it hasn’t really applied the idea to the fullest extent possible, Marks said.

“I think the mRNA platforms are going to force us to really try to lean into that," Marks added.

ONCY's pelareorep is a platform technology, that is able to address multiple cancers, with/without immune checkpoint inhibitors, ADCs bispecifics, chemotherapy, and small molecules like CDK4/6 and PARP inhibitors, as previously outlined.

https://www.fiercebiotech.com/biotech/were-open-business-fdas-peter-marks-says-agency-ready-review-novel-cancer-vaccines-despite

[Noteable]

In late 2022, the FDA took steps to enable "platform" technologies in drug development to expedite approval of groundbreaking technologies like novel processing equipment, cell lines, scaffolding, and bioprocessing technologies. In late 2023, ONCY took steps to scale-up is novel bioprocessing systems to address the need for the increased supply of pelareorep for the upcoming

[Noteable]

JohnnyYEG - your equivocating comments on Stocktwits appear to echo 'Mo' et al's posts here. If you are looking for me to be 'nice' then I advise that you keep looking, particularly if you are trying to push a particular contradictory agenda.

[Azzak34]

Big fan of your work Note but Johnny is one of the good guys. As is Saxy and Dude.  There's plenty of other clowns for us to have fun with. 

[Noteable]

Azzak34, I once thought the same. But like many on the ONCY message boards, including Saxy as well, their probity really swings in whatever direction they are trading.

[Azzak34]

I agree there's a whole load of fair weather friends over there but Johnny and Saxy have been fighting the good fight for years against everything thrown at them. I for one undersrand the odd wobble in faith. 

[Noteable]

Well they have been "wobbling" just a bit too much recently in my 'humble' estimation.

[itntdf]

is this a cut and paste error or did the fda really date stamp an article 4 months in advance? August 04, 2024 - The FDA's Peter Marks believes the FDA’s yet-to-be-formalized platform technology designation could be helpful.

[Buckhenry]

Now now now... let's not be questioning the omnipotent unnoteable..

[Noteable]

April 03, 2024  https://www.fiercebiotech.com/biotech/were-open-business-fdas-peter-marks-says-agency-ready-review-novel-cancer-vaccines-despite itntdf = stupid is as stupid be.

[itntdf]

guess i don't understand you comment.  this is your post and i was just questioning the date.  it's dated august 4, not april 4 so that seemed strange.  you usually post corrections so that's was basis for question. Post by Noteableon Apr 04, 2024 1:41pm FDA ready to review novel cancer vaccine Platform Technology August 04, 2024 - The FDA's Peter

[Buckhenry]

This post has been removed in accordance with Community Policy

[Noteable]

And I thought that Buckhenry's Backberry was obsolete ... I guess it isn't.

[Buckhenry]

Unnoteable's cut and paste skills are as obsolete as he is. 

[Buckhenry]

Got to love assak and peladuffus's mini me brown nosing skills for unnoteable 

[Noteable]

April 03, 2024    https://www.fiercebiotech.com/biotech/were-open-business-fdas-peter-marks-says-agency-ready-review-novel-cancer-vaccines-despite

[Noteable]

New medicines, particularly biologics in the treatment of cancer, are increasingly being identified as efficacious across multiple cancer indications and can be viewed from a commercial and reimbursement perspective as drug platforms. Increasingly manufacturers are prioritising the development and launch of multi-indication medicines and in terms of how medicines become available in a given

[Noteable]

ONCY's dsRNA  virus is the ONLY biomarker driven RNA oncolytic virus in late-stage clinical development with/without immune checkpoint inhibitors + chemotherapy.for the treatment of multiple cancers that is moving into registration studies that would support Accelerated Approval.

[Peladawn]

A virus that works and works well in all the right areas, and is now going into likely two registrational studies(maybe 3), that will support Accelerated Aproval!......Who the heck would be fool enough to invest in something like that, right Quentin?.....

[Noteable]

Who? Remember that lonc17 would have one invest in a phoney $3 bill rather than ONCY. That's also who.

[Peladawn]

Hey Note....how soon do think we'll hear something about the panc registrational trial?

[Noteable]

Repost :  - The FDA's Peter Marks believes the FDA’s yet-to-be-formalized platform technology designation could be helpful. The FDA recently issued draft guidance on the “advanced manufacturing technology” designation program, which was developed as part of the Food and Drug Omnibus Reform Act of 2022. The initiative is viewed as a step to