Replies to post #46335 on OncoSec Medical Inc (ONCSQ)

[trading.jeff]

Did he leave these points out because his bias is against OncoSec or because his research wasn't thorough enough?

$ONCS

[akhsv777]

Hschlaugh- much appreciated sharing your valuable thoughts!!! A great confirmation to me and others as well....it really means a lot.

[dangerM]

Indeed! Thanks for these comments. IMHO another important point is:

5. TAVO in addition to pembro is a really safe treatment, mostly with only grade 1/2 AE.

In regard to point 3./4. I'd like to highlight that Imlytic was approved on a 16.3% (!) "durable response rate"*. We only have a normal response rate and not a durable response rate as official clinical endpoint. But still, should there be an ADCOM then the durability of responses will be a very important point (if not the most important!).

The only caveat is that for accelerated approval there will be a comparison to the then approved therapies, but certainly not to IDRA (even if IDRA is able to complete their trial https://www.clinicaltrials.gov/ct2/show/NCT03445533?term=imo-2125&rank=1, this will rather mean an approval ~ 2022/2023 for them).

dM




*

https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM473103.pdf

The primary efficacy endpoint was durable response rate (DRR), defined as the percent of subjects with complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months. Tumor responses were determined according to World Health
Organization (WHO) response criteria modified to allow patients who developed new lesions or disease progression of existing lesions to continue the treatment and be evaluated later for tumor response. The DRR was 16.3% in the talimogene laherparepvec arm and 2.1% in the GM-CSF arm. The unadjusted relative risk was 7.6 (95% CI: 2.4, 24.1), with a p-value <0.0001.