Post by
inthno on Aug 19, 2023 12:06pm
MBC phase 3
Hopefully Panc should be settled soon and favorably.... It will be interesting to see if we try it alone or partner.
Just curious if anyone has concern with the new guidance for the mbc phase 3 trial which is now 550 patients as compared to the original 400 patients with a spa in the original December 5th 2017 press release from onc.
One would think that with all they learned from the aware1 , bracelet and new biomarkers that I thought it was supposed to reduce trial time, derisk the trial and lower the patient numbers especially with the use of the biomarkers...
Just curious on thoughts as I do find it confusing that we will now basically be running the same trial but with a much larger number of patients.
Thanks for the thoughts
Comment by
Buckhenry on Aug 19, 2023 1:29pm
I would not expect a Christmas card from unnoteable after that remark.
Comment by
Noteable on Aug 19, 2023 2:14pm
August 13, 2023 - SEDAR - (ONC.TO) MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS No mention of an increase to 550 patients for a P3 mBC trial from previously announced number of 400
Comment by
Noteable on Aug 19, 2023 2:41pm
ONC.TO Condensed Interim Consolidated Financial Statements (unaudited) Oncolytics Biotech® Inc. For the three and six months ended June 30, 2023 - NADA Nothng
Comment by
Noteable on Aug 19, 2023 2:33pm
inthno - I cannot find anything that you stated appearing in August 2023 SEDAR - no 550 patients, no FDA feedback in Q1 2024, no anticipated cost of $0.5 million - nothing inthnointhno
Comment by
inthno on Aug 19, 2023 2:42pm
So I am guessing you did not find the supplement and that the direct quote is wrong. Did you narrow the search peramiters and check all of the August filings.
Comment by
Noteable on Aug 19, 2023 2:49pm
I have checked all of the July and August SEDAR filings - NADA.
Comment by
Noteable on Aug 19, 2023 2:59pm
I have also checked all of the August SEC filings - NADA. So you must be seeing something that the rest of us dont OR it doesnt exist in the public domain.
Comment by
inthno on Aug 19, 2023 3:37pm
Hello Note and from my previous post where I copied and pasted, you should just be able to click on the prospectus supplement to get the filing...I just went to my post and clicked on it and it took me directly to the prospectus. Hope this works
Comment by
Noteable on Aug 19, 2023 3:52pm
Tried. No luck. Menu Go to Dashboard Franais Login The page you have requested can not be found. Ensure you are logged in if required, else contact your system administrator
Comment by
Normandt on Aug 19, 2023 4:45pm
550 patients is an estimated not an official guidance received from the fda.... for a normal phase 3 trial. 400 patients in 2017 was for a fast track phase 3 trial. Then I don't see where is the problem here.
Comment by
Noteable on Aug 19, 2023 5:55pm
Remember that Accelerated Approval provides that pelareorep can be approved in HR+/HER2- while the Phase 3 is running so ONCY should be going after this developing option during its iterative meetings with the FDA.
Comment by
Noteable on Aug 20, 2023 9:46am
With CelTIL as one biomarker : 70% of all cohort 1 and 2 patients (n=20) saw an increase in CelTIL from baseline to surgery 60% of cohort 2 patients (n=10) saw a CelTIL increase of at least 30% from baseline (pre-pelareorep administration) to surgery (21-days post-administration), exceeding the study's pre-specified success criteria
Comment by
Noteable on Aug 20, 2023 12:14pm
Should read: This view appears to place pelareorep in a favorable position for an early Accelerated Approval in mBC .... and reinforces the need for ONCY to pursue the FDAs actions in relaxing regulations involving early drug approval in diseases with unmet medical treatment needs, such as Her2- mBC, where ADCs are not indicated.
Comment by
Normandt on Aug 19, 2023 10:45pm
No , you don't understand the process. It's not hard to understand and we don't have to worry about that. 550 patients is estimated for a normal ph3 trial. They can not claim something that they should have when even the mbc ph3 is not yet announced.