Oncolytics Biotech Inc ONCY

How does Accelerated Approval work

[Noteable]

How does Accelerated Approval Work?

1. Application – standard 10-month review (unless expedited by a fast track/priority review designation) for efficacy, effectiveness, and safety.

2. Approval – FDA grants accelerated approval (prior to confirmatory trial) with specified timeline for required confirmatory trial(s) and post-market surveillance.

3. Post-accelerated approval – confirmatory studies conducted. From here, the FDA can convert the accelerated approval to a full, traditional approval if the drug confirms clinical benefit. If no clinical benefit is shown, the FDA has the regulatory authority to remove the drug from the market.

[Noteable]

Should read:  How does Accelerated Approval Work in Rare/Orphan diseases? " .... accelerated approval, which allows the use of surrogate endpoints that are not considered well established but that are determined to be “reasonably likely to predict clinical benefit.” FDA rules define surrogate endpoint as “a laboratory or physical sign that is used in therapeutic trials

[Noteable]

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit

[Noteable]

January 2024 -  FDA Unveils Groundbreaking Rare Disease Guidance Document For drugs eligible to follow the Accelerated Approval pathway, a determination of safety and effectiveness may be made based not on measures of direct clinical benefit, but rather on one of two alternative endpoints: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) an

[Noteable]

A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug

[Noteable]

May 07, 2024 - “The facts clearly show the accelerated approval pathway is providing new hope and meaningful new treatments for patients to fight their disease, and why we shouldn’t be misled by biased studies that distort reality,” concludes BIO. https://www.bio.org/gooddaybio-archive/setting-record-straight-accelerated-approval May 08, 2024 - "Using a biomarker to obtain accelerated

[Noteable]

May 08, 2024 - Accelerated approval—absolutely necessary for small, pre-revenue biotechs trying to find new treatments for small patient populations. That's according to the FDA’s Peter Marks, M.D., Ph.D., who was speaking at the American Society of Gene and Cell Therapy annual meeting.

[Noteable]

"Genentech’s Tecentriq won accelerated approval in 2016 for urothelial carcinoma but failed its overall survival endpoint in a Phase III trial the following year for patients with locally advanced or metastatic urothelial cancer who had been treated with platinum chemotherapy. It was withdrawn from the market in 2021 for this indication, with additional indications being

[Noteable]

By ONCY shifting gears into Cantor Fitzgerald, a US based global financial institution with  world-class specialized talent with a particular focus on healthcare, biopharmaceuticals, and technology, ONCY throws the doors open to opportunites that the Accelerated Approval pathway can bring for ONCY's pelareorep in combination with paclitaxel for the treatment of HR+/HER2- metastatic Breast

[Noteable]

By ONCY shifting gears into Cantor Fitzgerald, a US based global financial institution with world-class specialized talent with a particular focus on healthcare, biopharmaceuticals, and technology, ONCY throws the doors open to opportunites that the Accelerated Approval pathway can bring for ONCY's pelareorep in combination with paclitaxel for the treatment of HR+/HER2- metastatic Breast

[13X2413]

Combine the latest news with an upcoming fire side BS session and you get a $1.35 share price. 

[Noteable]

According to the FDA’s Peter Marks, M.D., Ph.D. the FDA's Accelerated Approval pathaway gives small biotech's a revenue stream to support on-boing clinical development in "orphan" and "unmet treatment need" diseases like pancreatic, breast, anal and colorectal cancers, which ONCY is currently in late stage clinical development, +/- immune checkpoint inhibitors.

[Noteable]

Should read: " ....gives small biotechs a revenue stream to support on-going clinical development ..."

[Noteable]

According to the FDA’s Peter Marks, M.D., Ph.D. the FDA's Accelerated Approval pathaway gives small pre-revenue biotech's a revenue stream to support on-going confirmatory trial activities and further clinical development in "orphan" and "unmet treatment need" diseases like pancreatic, breast, anal and colorectal cancers, which ONCY is currently in late stage

[Noteable]

So ... the sooner that ONCY confirms the design of the Phase 3 confirmatory clinical study in breast cancer (with the OS data being announced this H2), the sooner patients can be enrolled, and the sooner patients are enrolled, the sooner an Accelerated Approval request can be made, the sooner a revenue stream can happen to support on-going confirmatory trial activities and /or the sooner an

[Noteable]

Apparently ONCY has sufficient cash on hand to make all of the previous post happen.

[Noteable]

Unlike beforehand, the FDA has oficcially provided its guiidance on ONCY's Phase 3 mBC study ... And the sooner that ONCY confirms the design of the Phase 3, the sooner that ONCY will be able to announce that the trial will be corresponding to confirmatory clinical study in breast cancer (with the OS data being announced this H2). And that will happen as soon patients can be enrolled, and the

[Noteable]

Should read ... FDA has now officially provided its guiidance on the primary and secondary endpoints that would be included in ONCY's Phase 3 mBC study design ...

[Noteable]

ONCY'S  Phase 3 primary endpoint is PFS which is a surrogate endpoint for the Accelerated Approval process/request, and which has been explained ad nauseum for some who keep missing this point.

[Noteable]

FDA's Expedited Approval Mechanisms for New Drug Products "In December 1992, FDA also created the Accelerated Approval mechanism for full NDA approval through regulations. This mechanism applied to the approval of new drug products for serious or life-threatening conditions that provide meaningful therapeutic benefit to patients over existing treatments.It permitted the sponsor to

[Noteable]

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  And the FDA's Accelerated Approval is based on the above, and further objective criteria of therapeutic durability/clinical benefit, evidence of sufficient patient enrollment into an FDA

[Noteable]

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  And the FDA's Accelerated Approval is based on the above, and further objective criteria of therapeutic durability/clinical benefit, evidence of sufficient patient enrollment into an FDA

[Noteable]

" Accelerated approval (AA) targets candidates that are similar to those awarded BTD in terms of qualifying characteristics, such as aiming to treat serious conditions and providing improvements over current therapy. Most importantly, however, AA allows drugs to be approved using surrogate endpoints that are reasonably expected to predict clinical benefits. For example, for some

[Noteable]

" Breakthrough therapy designation (BTD) is granted for drugs aimed at treating serious or life-threatening diseases for which there is promising preliminary clinical evidence that shows superiority over current therapies. BTD does not guarantee future positive results in trials or successful approval, given that this designation is based only on preliminary data. As additional data

[Quentin30]

what does this have to dpo with ONCY...  we're beyond phase II meetings...  mBC we've now run IND213, and Bracelet-1. oh wait, yup, now we're planning a third Phase II... ALL this when the FDA 6 years ago granted ONCY a SPA for running a Phase III using Pela + Pax vs Pax alone. Go and check the company presentation slide deck from Feb 2018... Page 3 Positive feedback from

[Noteable]

This is for the benefit of Quentin30 - who doesn't own any ONCY stock BTW. " Accelerated approval (AA) targets candidates that are similar to those awarded BTD in terms of qualifying characteristics, such as aiming to treat serious conditions and providing improvements over current therapy. Most importantly, however, AA allows drugs to be approved using surrogate endpoints

[Noteable]

“The accelerated approval program may lower the operational hurdles for launching the above-mentioned products by allowing studies with surrogate endpoints to be reviewed for early approval, in which the sample size is smaller and the results are available more expeditiously than studies with true endpoints,” wrote Satoshi Kato and Shunsuke Ono, of the laboratory of pharmaceutical regulatory

[Noteable]

September 17, 2024 -  21 USC 356: Expedited approval of drugs for serious or life-threatening diseases or conditionsText contains those laws in effect on September 17, 2024 From Title 21-FOOD AND DRUGSCHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER V-DRUGS AND DEVICESPart A-Drugs and Devices  Accelerated approval of a drug for a serious or life-threatening disease or

[Noteable]

ONCY is set to run 2 trials in 1 in their planned adaptive designed180-200 Phase2b -> Confirmatory clinical trial -  (a pivotal accelerated approval trial powered to a surrogate endpoint and a confirmatory regular approval trial powered to a clinical endpoint) “Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model,”  In the absence of accelerated

[Noteable]

February 23, 2023 - European Medicines Agency (EMA) Committee for Medicianl Products for Human Use (CHMP) grants Accelerated Approval for a vaccine candidate based upon CHMP's decision that the vaccine candidate is of major interest for public health and therapeutic innovation. Logic dictates that ONCY's pelareorep candidacy for use in combination with an immune checkpoint inhibitor, in

[Quentin30]

would be of major interest... sure... but without validated biomarkers and statistically significant data relating said biomarker to OS, then NO Accelerated Approval will be forthcoming.. Not from EMA, SFDA, CFDA, FDA or Health Mongolia... ONCY have stated they will run a regular Phase III... what is your obsession with accelerated approval when ONCY management discount it themselves.. who are

[Noteable]

Simple .. AWARE-1  was a biomarker study. Biomarkers in mBC also translate to pancreatic cancer. How many more times need I point this out!

[Noteable]

https://www.prnewswire.com/news-releases/oncolytics-biotech-and-solti-achieve-primary-endpoint-in-aware-1-study-301266442.html

[Noteable]

https://www.prnewswire.com/news-releases/oncolytics-biotech-and-solti-present-further-positive-pelareorep-translational-data-at-sitc-301977019.html

[inthno]

Hello Noteable, you are posting a news release that is now almost 3 years old. The company should have been able to go ahead with the phase 3 as a result or made more progress by now as the aware 1 was specifically for the biomarkers in relation to the mbc trial. Oncolytics Biotech® and SOLTI Achieve Primary Endpoint in AWARE-1 Study News provided

[Noteable]

Blame Quentin30 who said that ONCY needed biomarkers to apply for an Accelerated Approval. So I provided the proof of ONCY's biomarker development. Don't you follow what is going on inthno OR don't you happen to understand again?

[inthno]

The only thing I do not understand is you thinking you are God and no everythng that is going on and that no one else may possibly be right or have an opinion. So tell me since you know it all, why do we not have AA as you seem to have been talking about it forever?

[Noteable]

As someone said recently.. "Don't compare me to God .. Compare me to the alternative! "

[Normandt]

You don't even understand the difference between a fact and an opinion. How can you pretend to understand Notable's explanations. Noteable responds to a false comment and responds by providing additional proofs.... and you respond that it's old news. Wake up superman! You seem more credible when you ask questions and reply to yourself in long false exchanges on yahoo or on

[Noteable]

https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-clinical-and-biomarker-data-demonstrating-clinical-proof-of-concept-for-pelareorep-checkpoint-inhibitor-combination-in-pancreatic-cancer-301295729.html

[Noteable]

https://oncolyticsbiotech.com/press_releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-1-2-study-at-esmo/

[13X2413]

Thanks for the 2021 info. Add it to the pile of useless, outdated information. 

[Azzak34]

Boooooooooo!! You stink. 

[Noteable]

ONCY's pelareorep has been granted fast track and orphan drug (rare disease) status in both pancreatic cancer and advanced/metatstatic breast cancer. In the rare disease policy space, all roads invariably lead back to the Orphan Drug Act’s (ODA) enactment. In 1983, Congress passed the ODA to amend the Food, Drug, and Cosmetic Act — the U.S. law governing the approval of medicines — to include

[Quentin30]

That's all very lovely Notable... But to get market exclusivity, you need an APPROVAL... and ONCY's key patents will start expiring in three years... is that enough time to get approval... Fast track assessment is 6 months in itself... so ONCY has 2 and a half years... and the clock is ticking... tick tock, tick tock...

[Noteable]

In the case of Orphan / Rare diseases and in diseases with unmet treatement needs, the FDA appears to have a tendency to grant  drug Accelerated Approvals much quicker than otherwise, and they do so in an overall effort to drive patients suffering from these diseases into the registration studiies earlier than could happen normally. 

[Noteable]

In the case of ONCY's biomarker driven registration studies, the number of enrolled patients for a Phase3/4 post approval confirmatory trial should be nominal due to the nature of the number of available patients with these Orphan / Rare conditions, and the urgency that having a serious cancer with an unment treatment need creates, such as with both advanced/metastatic pancreatic (PDAC) and

[Noteable]

Endpoints reported today that OV company Replimmue "aims" for accelerated approval for their intratumorally delivered OV + nivolumab (Optivo) in the treatment of melanoma after reporting a 28.3% all subgroup overall response rates (ORR) in its RP1 IGNYTE Phase 1 clinical trial in PD-1 failed melanoma patients. https://endpts.com/replimune-aims-for-accelerated-approval-of-melanoma

[Noteable]

Which Types of Surrogate Endpoints Are Used for Accelerated Approval? The FDA accepts surrogate endpoints for clinical studies of pharmaceutical products in several instances. Approval decisions through the traditional review pathway can be based on a validated surrogate endpoint, if one is available. The FDA can deem a surrogate endpoint to be validated if it is “supported by a clear mechanistic

[Noteable]

The Accelerated Approval Process (AAP) does not use validated surrogate endpoints. It was designed to consider surrogate endpoints that meet a lower standard of being “reasonably likely to predict clinical benefit.” The below referenced link outlines ONCY's novel biomaker/surrogate endpoint clinical results that qualify pelareorep for the Accelerated Approval Process involving a new

[Noteable]

https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-inc?postid=36092904

[Noteable]

Accelerated Approval -> $$$$$$$ 

[Noteable]

By ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as

[Noteable]

By ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as

[Noteable]

And I posted on the Accelerated Approval process for that long .... So by ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and

[Noteable]

A primary endpoint for ONCY'S  Phase 2 metastatic breast cancer (Bracelet-1)  of overall survival (OS) has been maturing and the 2 year data timeline was reached at the end of May- early June 2024.  The effect of having extended data on OS should make for even more ccompelling request for an FDA Accelerated Approval for pelareorep (monotherapy) + paclitaxel in mBC. By ONCY

[Noteable]

According to the FDA’s Peter Marks, M.D., Ph.D. the FDA's Accelerated Approval provides small biotech's with a revenue stream to support on-going clinical development in "orphan" and "unmet treatment need" for diseases like pancreatic, breast, anal and colorectal cancers, which ONCY is currently conducting and in late stage clinical development, +/- immune

[Noteable]

Regarding future funding .. according to the FDA’s Peter Marks, M.D., Ph.D. the FDA's Accelerated Approval provides small biotech's with a revenue stream to support on-going clinical development in "orphan" and "unmet treatment need" for diseases like pancreatic, breast, anal and colorectal cancers, which ONCY is currently conducting and in late stage clinical

[CMHarring218431]

Morning Noteable  I believe I have thanked you a few times for posting essential data relative to Oncy's success and the highlights of what is most poignant and your associated personal insight. But why the constant repetition? Have you been hired as the in house promoter? Although, you confess to claiming that Oncy is a no brainer....are you silently just worried about your investment

[Noteable]

" But why the constant repetition?" Ask those who keep missing what I post the first time and then repeately thereafter.

[Noteable]

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint, like progression free survival (PFS), is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical

[Quentin30]

brilliant...  Accelerated Approval is possible with two randomised Phase IIs... but now we're going to run a third phase II.... That's interesting isn't it. ONCY will pay for it on their own... LOL... no they won't... shareholders will pay for it... they'll make the case after Bracelet-1 OS data is (finally revealed) that if they reverse split... then they can get the

[Noteable]

3 registration studies that are already in progress - 1 in mBC (Bracelet-1) and 2 in mPDAC (Goblet-1).

[Noteable]

All 3 registration studies are adaptive Phase 2 studies that can seamlessly morph into and through the Phase2b/ Phase 3 / confirmatory study continuum by the very nature of the adaptive clinical trial design. I suggest that you read my earlier posts before commenting any further, as all this has been already discussed. 

[inthno]

Hello Note and you wrote...; Comment by Noteableon Sep 10, 2024 4:44pm RE:RE:RE:RE:RE:RE:How does Accelerated Approval work 3 registration studies that are already in progress - 1 in mBC (Bracelet-1) and 2 in mPDAC (Goblet-1). I do not see anywhere that shows we have 3 registration studies underway. We do not have any trial protocols or any fda approvals yet. If you mean that the

[Noteable]

By ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as

[Noteable]

And for those who don't read or understand what has already been posted  ...  this was posted on Apr 15, 2024 2:38pm In the case of Orphan / Rare diseases and in diseases with unmet treatment needs, the FDA appears to have a tendency to grant  drug Accelerated Approvals much quicker than otherwise, and they do so in an overall effort to drive patients suffering from these

[Noteable]

RE:RE:RE:RE:How does Accelerated Approval work And for those who don't read or understand what has already been posted  ...  this was posted on Apr 15, 2024 2:38pm In the case of Orphan / Rare diseases and in diseases with unmet treatment needs, the FDA appears to have a tendency to grant  drug Accelerated Approvals much quicker than

[Noteable]

June 24, 2024 - Bristrol Myers Squibb's KRAS inhibitor has been granted Accelerated Approval as part of a combination treatment for a subset of colorectal cancer (CRC) patients. The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study which evaluated KRAZATI. The study met its primary endpoint, with a confirmed ORR of 34% (n=94, 95% CI: 25-45) for

[Noteable]

Twenty-five patients were enrolled in BMS's Phase 1/2 KRYSTAL-1 study of adagrasib in non-small-cell lung cancer, colorectal cancer, and other solid tumors harboring the KRASG12C mutation and received at least one dose of adagrasib.  16 patients had NSCLC and 4 patients had colorectal cancer (CRC). Adagrasib 600 mg twice a day was well tolerated and exhibited

[Noteable]

June 25, 2024 -  Inside the FDA's Accelerated Approval: How it’s extending lives and improving patient care https://www.outsourcing-pharma.com/Headlines/Markets-Regulations/How-does-the-FDA-s-Accelerated-Approval-Program-impact-patients

[Noteable]

June 20, 2024 - FDA CBER (biologics) Director speaks to another accelerated approval pathway for rare diseases under the Promising Pathway Act, which has been introduced in both chambers of Congress. [ Pancreatic cancer is considered a rare disease, accounting to 3% of all cancers in the United States ] https://www.elcaminohealth.org/stay-healthy/blog/pancreatic-cancer-rare-and-little-known

[Noteable]

According to FDA guidance entitled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics" .... . .. "While durable ORR has been used as a traditional approval endpoint n some circumstances, ORR has also been the most commonly used surrogate endpoint in support of accelerated approval. Tumor response is widely accepted by oncologists in guiding cancer treatments

[m00nsh0ts]

Why don't we have accelerated approval right now?

[Noteable]

The FDA request for an Accelerated Approval is usually made with the filing of the Phase 3 design (which is then considered as the confirmatory study design) and the enrollment of the first number of trial patients. I would think that ONCY's partner or acquirer would want to be responsible for administering these final registration steps to ensure pelareorep's approval,  and to ensure

[Noteable]

.... pelareorep's proposed combination with multiple other I/O agents, like immune checkpoint inhibitors, bispecifics, CAR-T, ADCs, and small molecule drugs, such as CDK4/6 and PARP inhibitors.

[Quentin30]

In a presentation late last year, a fireside chat I think, Matt stated that the Phase III for mBC would be a standard double blind study. Dr Heineken stated that the bracelet-1 trial was not designed for statisical significance..? kinda begs the question why run the effing thing then, but hey ho... There will be NO Accelerated Approval... if it were a possibility, ONCY management would have

[Noteable]

And who is Dr. Heineken? Is he the beer baron of bratwurst?

[Noteable]

Furthermore, the Inflation Reduction Act provides 13 years of market exclusivity fto a novel biologic, which occurs from the time that the biologic is approved by the FDA. ONCY's pelareorep is a novel biologic that is eligible for this 13 years of market exclusivity, notwithstanding that ONCY's patent portfolio is vaild unti at least 2031.

[inthno]

I do have a question which no one seems to be able to answer in regards to the patents. This is from the Jan. 2023 investor presentation. 31 Robust Intellectual Property Portfolio As of January 18, 2023 240 patents issued worldwide, including 21 US and 11 Canadian 17 pending applications worldwide Reovirus issued patent claims cover: Compositions of matter comprising reovirus Through 2028 and

[Noteable]

Well I suppose that can be left up to any Big Pharma acquirer of ONCY, even as the 13 years of market exclusivity provided by the IRA that was passed in 2022, has made the importance of patents for biologics rather obsolete, given the nature of biologics.

[inthno]

Yes note that is true but we still need someone to step up and time is running short.and.so we hope and wait.

[Noteable]

Which Types of Surrogate Endpoints Are Used for Accelerated Approval? The FDA accepts surrogate endpoints for clinical studies of pharmaceutical products in several instances. Approval decisions through the traditional review pathway can be based on a validated surrogate endpoint, if one is available. The FDA can deem a surrogate endpoint to be validated if it is “supported by a clear mechanistic

[Noteable]

The FDA recognizes biomarker development as a high priority area for future research and accelerated drug approvals. June 30, 2024 - Key Guidelines for Accelerated Approval Surrogate Endpoints: Drugs that receive accelerated approval are approved under the program based on surrogate endpoints that are reasonably likely to predict clinical benefit. Such endpoints indicate the

[Noteable]

What does Accelerated Approval mean? Accelerated approval refers to a regulatory pathway of the FDA that allows drugs for serious conditions, which are intended to fill an unmet medical need, to be approved based on a surrogate endpoint. This pathway is typically faster in obtaining the necessary data from clinical trials than the traditional approval pathway based on clinical endpoints (how a

[Noteable]

List of : CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint - As of March 31, 2024 -  Total Approvals 310 https://www.fda.gov/media/151146/download?attachment 75% increase in FDA Accelerated Approvals based on a Surrogate Endpoint since December 03, 2022  https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approvals