Oncolytics Biotech Inc T.ONC

ONC/Y and the FDA

[Capitalista]

Like most, I am concerned about both the complete lack of info on potential buyout offers and the expiry of Pfizer's 90-day exclusivity period on Bracelet-1.  The lack of info is understandable given the need for confidentiality in negotiations; the exclusivity period expiry is a bit more troubling.  

I'm wondering if the "radio silence" is due to ongoing talks with the FDA.  Given that Pela has been given fast-track designation for two indications and that there have been no serious adverse reactions to Pela after hundreds of doses given, the two treatment combos (for BC and Pancreatic Cancers) should be excellent candidates for Accelerated Approvals.  It is certain that ONC/Y is in talks with the FDA about the design of the trials; it is highly likely they are discussing the trial designs assuming an AA would be granted for one or both indications.  

If this were the case, ONC/Y would likely be delaying negos (or at least decisions) on buyouts.  An AA for either indication would provide the cash flow necessary for both Phase III trials without the need for dilution or  capital injection from a partner (buyout or otherwise).   This would avoid the buyout price "haircut" due to ongoing risk in purchase of a company which hasn't gone beyond Phase II yet. In other words, getting an AA is preferable to a buyout and ONC/Y may be proceeding on that basis.

[westcoast1000]

That is a thoughtful comment, Capitalista. Thanks

[venture009]

An AA is something we would all like but I don't think it's going to happen.  The FDA is in the BP back pocket and an AA wouldn't be in their best interest. 

[Capitalista]

Do you have specific knowledge of this in the case of ONC/Y, venture009?  I looked online for corruption/bribery issues involving FDA and only found a handful mentioned in the last five years or so.  FDA is overseeing thousands of trials a year.  I'd suggest it's a small problem.   There is an issue with the pharma industry providing funding to FDA - there are

[Quentin30]

I would add to this vebture009. My work involves dealing with the FDA, and they do everything they can to guide companies to get treatments (that are really needed) to market. They have never been anything but helpful and instructive. As for funding... I think the way you state this, gives cause for concern. But FDA is funded by licences for given products... It's around 350k per product

[westcoast1000]

Thanks to Quentin for this valuable comment. I agree entirely. I formerly had some professional interaction with a few FDA officials and I found them to be highly professional and motivated by serving public health while following the precedent in official process. That said, I cannot understand why they do not more effectively embrace the concept of balancing risk and benefit that they were

[Quentin30]

HI WestCoast, This may be ONCY's achilles heel actually... Pela is to be used with the current standard of care, Paclitaxel, which has the following commonly reported side effects. Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling

[westcoast1000]

Quentin, Yes, you are right, pela has been tied to pacitaxel in the combo trials. And we could only wish that it worked as well on its own as with the toxic agents. And I agree, aspirin would likely not get approved today. Although perhaps the risk/ benefit reasoning I talked about would have allowed aspirin, given it can be dosed properly.  When I was a kid, I used to be given aspirin

[westcoast1000]

Should be: "We do NOT know..."

[venture009]

Quentin30 it is difficult to be completely independant when a portion of your operating review relies on the companies you're to be overseeing. This was particularly evident with Pfzier when FDA  attempted to withhold test results from their covid vaccine for decades until a judge ordered a release with in a year. I had meant to mention that an AA is unlikely because of such a small test

[Quentin30]

Agreed. The trials are so small as to limit any definite conclusions... are you really seeing 60% ORR or is that just noise from such a small sample size... What company is going to pay 8 billion, for a company valued today at less than 100 million. ONCY won't have distinction between OS between pel + Pax arms, and Pela + Pax + CPI until next year... So if this now drags into 2024, how can

[venture009]

Amen to that. Twenty three years and counting.