Titan,
I disagree slightly with the commercialization timeline suggested by McCarthy, primarily because I think ONCS WILL secure Accelerated Approval with the upcoming phase II combination EP IL-12 and Pembrolizumab trial (i.e. the trial that has not started yet - the "registration" trial). I try to run the math on even the most conservative outlooks, which in my view is exemplified by McCarthy's review. I prefer to be pleasantly surprised than to be caught off guard and disappointed. I don't think McCarthy makes assumptions about Accelerated Approval, therefore his 2022 commercialization estimate reflects a reasonable perspective.
Here is another possible timeline:
Oncosec will secure a Breakthrough Therapy designation sometime in 2017 based on the currently-enrolled Phase II metastatic melanoma trial combination data. This trial, as you know, will have interim data out next month, and should be wrapping up in the first half of 2017. Per PD, enrollment should be complete by the end of the 2016 calendar year. Assuming ONCS submits for Breakthrough Therapy designation, it will take the FDA up to 60 days to respond with an approval or denial.
The Phase II metastatic melanoma combination "registration" trial will commence in 2017. The FDA will work closely with ONCS on expediting enrollment and trial completion, owing to the Breakthrough Therapy designation.
Sometime in late 2018, we will know whether or not the "registration" trial met primary and secondary endpoints.
In early 2019, ONCS will submit a NDA for Accelerated Approval in the indication of advanced metastatic melanoma using EP IL-12 combined with Pembrolizumab.
In late 2019, ONCS receives Accelerated Approval based on the submitted NDA.
Commercialization begins in 2020, thus shaving off two years relative to McCarthy's estimate.
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To answer your questions...
The phase 2 proposed AA-design trial mentioned in slide 20 is the "registration" trial for refractory patients. In other words, ONCS thinks they can secure an Accelerated Approval based on the trial design - obviously this is dependent on positive efficacy and safety. Per NIH definition, refractory is "cancer that does not respond to treatment. The cancer may be resistant at the beginning of treatment or it may become resistant during treatment." I interpret this to include all non-responders (resistant at the beginning of treatment), partial responders (become resistant - they still have metastases), or recurrent complete responders (become resistant - disease returns due to residual disease). Therefore, it includes the vast majority of metastatic melanoma patients. I look at "non-responders" as more of a specific sub-category of "refractory".
I agree with you about the post-approval trial stipulation required after AA.
