Oncolytics Biotech Inc T.ONC

Latest news very good

[canadafan]

The most recent newsprogressing with another phase if the Gobblet trial co- therapy with Roche can only be viewed as good news. Ideally Roche steps up & buys the whole company. It was always noted by management, Majority of acquisitions came on the results of long standing clinical relationships. They certainly have that with Roche. Not to mention the phase 3 fast track approval for the pancreatic cancer co therapy.

[JohnnyYeg]

AND the FDA has accepted the sBLA (supplemental Biologics Application) and assigned a PDUFA (Prescription Drug User Fee Act) goal date of October 8, 2024

[Noteable]

The FDA assigning ONCY a PDUFA date for a supplemental Biologics Application (sBLA) is fake - and doesn't appear on any FDA calendars. This is because ONCY currently does not have any approved products for a "supplementary" BLA to be filed against.  https://www.benzinga.com/fda-calendar?date_from=2024-10-01&date_to=2024-10-19&securities=ONCY

[Noteable]

" Supplement - A request to FDA to approve a change to an approved license application." FDA Standard Operating Policy and Procedure (SOPP) guideline - SOPP 8401.2: Administrative Processing of BLA and NDA Supplements Version: 10 Effective Date: February 8, 2024 https://www.fda.gov/media/108895/download

[JohnnyYeg]

Correct Noteable - my bad. It was a misleading link header that used the ONCY ticker symbol and the FDA PDUFA details when in fact the PDUFA mentioned in the article was for Bristol Myers Squibb's section in the article. My apologies folks.

[lonc17]

A buyout by Roche could happen anytime. It needs to happen very soon otherwise ONC is facing a capital raise that will decimate existing shareholders. No one "invests" by buying shares in ONC at this time. It is a pure speculative gamble with a timeframe of less than two months. Roche buyout... you win at least 10x Dilutive financing ... you lose half your money, likely never to see

[lonc17]

Really if you are doing and expected value calculatoin then you may consdier the possiblility of 20x (or even 30x if bidding war ensues). But MC would need a team of expert negotiators to pull that off.