Oncolytics Biotech Inc ONCY

RE:RE:RE:EY sees bolt-ons in the single to double digit billions now

[Noteable]

In concert with the recent Executive Order on securing the American Bioeconomy. the Brookings Institute proposed a financial strategy for the social investment program in emerging biopharmaceuticals which would build on existing successes of BARDA, and some more limited non-governmental programs.

Such an arrangement is having Big Pharma companies seeking late-stage biopharmaceutical assets to acquire prior to product approval so that they would be able to access government funding for the development of innovative biopharmaceutical companies AND an innovative biopharmaceutical company like ONCY "fits-the-bill".

The key is that the funds can be deployed at risk—in other words, before the product has been approved or authorized and is available for purchase. Therefore, financial participation would have two components: forgivable loans and cost sharing requirements. Loans would be forgivable if the funded project failed to attain a defined commercial (revenue) threshold. Repayment terms would include an interest rate that was below the lowest expected return project adopted in the private market. Market analysis would be required to determine the proper cost-sharing rates, or we could adopt an EU-like partnership model that amounts to a form of cost sharing. Together, these provisions would eliminate a substantial portion of the downside financial risk of the largest cash outlay in the R&D process. Efforts should also be made to reduce perceived conflicts of interest. 

These initiatives would require cooperation and regulatory adjustments by the FDA. In the development of new cancer therapeutics and medical countermeasures, NIH’s and BARDA’s support for targeted clinical trials has been complemented by FDA’s novel efforts to lower the barriers to product launch and improve the availability of therapeutics. These efforts include the revision of trial endpoints for product provisional review and approval and the acceptance of alternative trial design, including basket trails, challenge trail, and Bayesian adaptive design trials as well as other efforts to confirm safety and efficacy thus making it easier for innovative biopharmaceutical products to gain FDA marketing approval. These efforts could be expanded to address targeted areas of unmet need. 

Such US government participation further de-risks innovative products like ONCY's Immune Molecule Platform Technology for ultimate approval in multiple cancer indications and thus making ONCY a very attractive M&A target for multiple Big Pharma companies, who would have the US government sharing in the costs of pelareorep's future clinical trials and approval in various cancers.