Oncolytics Biotech Inc ONCY

AA ?

[ScootsMcgoots]

Hi Noteable. I am a committed shareholder. New to this board, usually on ST. I do not think AA is in the cards pre-P3 on mPDAC for two reasons and that's the fact that this is a combination therapy so it's a bit harder to prove what is causing efficacy to the FDA, add to that the small trial size. If this were a monotherapy then this would have been done already. This is why the company has clearly communicated repeatedly that an adaptive P3 is needed. An adaptive P3 will have surrogate endpoints and frankly it shouldn't take too many patients to show that this works, whether by ctDNA or ORR/PFS at around 6 mos at the FDA's whim, and then at that point yes AA. It shouldn't be a full P3 to get there. It's doable even for little ONC maybe a 40-50mm raise total. 

This is a pretty good article explaining:
https://ascopubs.org/doi/full/10.14694/EdBook_AM.2012.32.114

Re SCCA, that combo doesn't involve chemo. There's plenty of trials showing very limited efficacy for Atez, so a nonrandomized small sample size for an indication with no SoC there's at least a shot there for an early AA.

(https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.3508)

[ScootsMcgoots]

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01658-0/fulltext Here's another study Atez alone. Main takeaway is no effect. So it's pela. Are we off to the races? Maybe is the best anyone can say right now. They will meet with the FDA and find out. 

[13X2413]

Where the heck have you been? Finally some accurate, relevant and intelligent information.  If you were around here earlier, you may have saved me some money.  Dying to see how the over the top pumpers put their spin on this. I bet it involves news on buyouts of random BP companies. 

[Noteable]

If you understand what I had been posting you would have seen the evidence that the issuance of an Accelerated Approval to pelareorep would result in an immediate revenue stream that would be applied towards the Phase 3 confirmatory study and preclude the need for any subsequent capital raise. Furthermore we already know that checkpoint inhibitor monotherapy is ineffective due to an

[TMAZZ21]

Hi Noteable, you been posting on this site for how many years now? After a while it's beginning to sound like a Martin Luther King's speach                   I Have a Dream But the reality is we are sitting @ under $2, maybe your reality needs to realize that you been dreaming for far too long!

[Buckhenry]

More like... I had a nightmare....

[Quentin30]

"In addition, the BRACELET-1 study demonstrated that pelareorep is an active agent . The pelareorep + paclitaxel combination was more effective than paclitaxel alone, indicating that pelareorep enhanced the combination over either drug as a monotherapy." NO, it didn't demonstrate this, it confirmed it...  IND-213 demonstrated this effectiveness, and all they had to do was run a

[Noteable]

OK ...  it confirmed it. And by virtue of the Bracelet-1 results the study results went on to interpretedly confirm that pelareorep + paclitaxel + atezolizumab was effective in advanced or metastatic pancreatic cancer AND that this combination would very likely be effective in metastatic breast cancer since atezolizumab is a PD-L1 blocker that has its Fc component silenced

[Noteable]

Fc Silencing Improves Anti-Tumor Activity as evidenced by:   https://absoluteantibody.com/general/pd-1-fc-silent-improves-anti-tumor-activity/

[Quentin30]

and while the addition of Tecentriq was intrepreted as additive, it still needs to be proven out in a Phase II. This is why Matt stated that addition of a CPI would be done as a post approval activity. It makes sense, generate a revenue stream, and then adapt the combination to entice a Big Pharma buyer/partner... So it's a pity that they didn't take this approach 5 years ago... a

[Noteable]

And on that point of post-approval activity ... such approval would result from the granting of accelerated approval in multiple Phase I/II Goblet-1 indications including advanced or metastatic pancreatic and SCCA (anal) cancers. Either ONCY or more likely Big Pharma can then conduct a Phase 3 confirmatory clinical trial in te aforementioned cancers, while

[inthno]

We need to get panc or Anal into a phase 3 trial asap and hopefully an adaptive trial where they can have a look and then possibly grant AA as a result. Because the patient numbers are so low in both the panc and SCAA it is unlikely at this time that AA would be granted but maybe the FDA would look at the overall picture of the Panc and SCAA and can see that it is showing efficacy and you just

[Buckhenry]

Nothing to hold the stock price. Could test the 0.82 cent level soon.