OncoSec Medical Inc (ONCSQ)

[inv10001]

The key case to watch over the next few months is GM604 and the very public campaign for accelerated approval. There is a paradigm shift occurring in the drug development industry. You will not see the full effect for several years so the precedents you want will not exist. If you want to be successful investing you better understand the shift that is coming. You might be surprised on a case by case basis the decisions that will occur. GM604 may fail given some debate on the effectiveness, nevertheless, the paradigm shift is coming. Ultimately, for ONCS what happens depends on the clinical results. While unlikely, what would you think would happen if the results showed 100% response in the 41 patients? Since that is unlikely, it becomes more tricky to predict what would happen at lower response rates. I do not think anyone is stating that accelerated approval will definitely occur. However, if you investigate the design of the trial, read the literature on what is currently occurring at the FDA, and realize the following:

1) It meets the criteria of a terminal disease
2) No alternative treatment / unmet medical need (as it is designed to test outcome on those with no/low response to current treatments)
3) Predictable outcome based on theoretical cause of action + post treatment data to confirm cause of action. Remember the Perkin Elmer collaboration?

It becomes clear that if results are positive enough (and this is the key) then an application for accelerated approval could and is likely to be filed. Good companies do not wait for precedent, they set the precedent and pave the path to the future.