The press release was indeed positive with the best possible outcome being that we have pfs as the primary endpoint.
1)What we now need to know is the number of patients to complete the trial
2)The use of biomarkers was not mentioned in the pr but we can assume that this will be included in the final trial design.
3) This is the main purpose of the type c meeting.....
What is the difference between a Type C and Type D meeting?
Note: Type C meetings include meetings to discuss early consultation on the use of new surrogate endpoints. 5. Type D Meeting - A meeting focused on a narrow set of issues (should be limited to no more than 2 focused topics) and should not require input from more than 3 disciplines or Divisions
4) From sept 18th 2017- This is the original intended patient population.... Oncolytics’ proposed target population for its phase 3 study of pelareorep is patients with HR+/HER2- mBC, which represents approximately 73 percent of metastatic breast cancer cases that have limited treatment options that offer survival benefit
5) We now have a new patient population
The Company’s proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.
So this narrows the patient population that we can treat at this time
6) So will a partner step up now is the big question as we know this is the only way they can continue on to the registration enabling trial.
7) There is still a lot more to determine with the trial peramiters, the setting up of sites and a partner so IMO the earliest this trial can get started is in 2025 and preliminary pfs results most likely in 2026 which if good could lead to early approval or possibly AA and still gives time before the expiration of patents.
8) I am still thinking that the earliest route to approval could be the SCAA (anal) trial is it has already started enrolling the next set of patients with results expected in 2025 and so we wait and hope for the best with this trial.
9) The above of course is only my take and IMO and nice to know that this pr is starting to lay out the groundwork for the next step in the registration enabling trial.