Oncolytics Biotech Inc ONCY

Big Pharma walks away from gene-therapy biotech

[Noteable]

https://www.fiercebiotech.com/biotech/biogen-and-novartis-deliver-one-two-punch-sangamo-walking-away-deals-quick-succession

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In December 2022 Quentin posted the following " My point is, whilst we wait for more Phase II data, the field is moving... away from chemo + Pela + CPI, to Gene edited cures. What do you think the better investment is ?" The answer to Quentin's question became very evident this month as Big Pharma announced their decision to move away from gene therapy aka gene editing.

[Noteable]

In December 2022 Quentin posted the following " My point is, whilst we wait for more Phase II data, the field is moving... away from chemo + Pela + CPI, to Gene edited cures. What do you think the better investment is ?" The response to Quentin's question became very evident then and even more evident today with Takeda walking away from it gene therapy investments.....

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And just to remind the readers here .. "In December 2022 Quentin30 posted the following " My point is, whilst we wait for more Phase II data, the field is moving... away from chemo + Pela + CPI, to Gene edited cures. What do you think the better investment is ?" The response to Quentin's question became very evident then and even more evident today with Takeda walking away

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May 10, 2023 -  Is there enough evidence to support accelerated approval for use in ambulatory patients who have a confirmed mutation of the DMD gene?  The FDA, for its part, seems to be unconvinced.  https://www.fiercebiotech.com/biotech/fda-questions-benefits-risks-sarepta-dmd-gene-therapy-concern-thats-thrived-2018

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May 12, 2023 - FDA advisers have narrowly voted in favor of Sarepta’s gene therapy for patients with Duchenne muscular dystrophy, a stunning decision that runs counter to regulators who expressed skepticism last week heading into the meeting.  [This is a prime example that illustrates that if Sarepta's gene therapy can receive the FDA's Advisory Committee "go-ahead" for FDA

[westcoast1000]

Based on my experience in a small involvement with the FDA in a series of conferences a few years back, the organization relies on a "panel system" which involves affected groups and academics to provide advice to the regulatory process on whether drugs should be approved. Their deliberations likely involve input from the FDA officers who have responsibility for the approval process for

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Times are a changing ... https://www-nbcnews-com.cdn.ampproject.org/v/s/www.nbcnews.com/news/amp/rcna63662?amp_gsa=1&amp_js_v=a9&usqp=mq331AQIUAKwASCAAgM%3D#amp_tf=From%20%251%24s&aoh=16841127023212&referrer=https%3A%2F%2Fwww.google.com&ampshare=https%3A%2F%2Fwww.nbcnews.com%2Fhealth%2Fhealth-news%2Ffda-broke-protocols-approving-biogen-alzheimers-drug-congressional-rep

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Congressional Report: U.S. FDA Broke Own Protocols in Approving Biogen Alzheimer's Drug Reuters - Dec. 29, 2022

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May 15, 2023 - Sarepta Therapeutics was handsomely rewarded by investors early Monday after FDA advisers surprisingly voted in favor of the accelerated approval path for the company’s Duchenne muscular dystrophy gene therapy Friday evening.  Sarepta’s shares were up more than 24% shortly after the market opened Monday, from $120.20 apiece to roughly $150.  https://www.fiercebiotech.com

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Sarepta's only placebo-controlled, randomized data company came from part 1 of phase 2 trial 102, which did not show a statistically significant improvement in treated patients as measured by a motor function scale.  Yet the company was given a 'thumbs up' by the FDA's Advisory Committee and is trading at US$150 per share today.

[fox7mf]

Oncy is at $2.22 a share...$150 may be a pipe dream. 

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With Sarepta as an example, US$150 per share for ONCY is not out of the question which would give ONCY the US$10 Billion buyout previously noted.

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June 02, 2023 - Takeda is another Big Pharma company to divest its interests in gene therapy. https://endpts.com/takeda-ends-2021-deal-with-poseida-therapeutics-to-develop-in-vivo-gene-therapies/