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Monday, October 17, 2016 2:33:40 PM
Also wanted to get your thoughts on the accelerated approval trial design they mention in slide 20 of the corporate presentation.
http://content.equisolve.net/oncosec/media/2d5a7ab57e422af958a91c398faf2545.pdf
Is it correct to say this trial is not the registration trial they talk about? This phase 2 AA-design trial seems to be only for refractory patients to Keytruda. Is the registration trial going to be a phase 3 trial for non-responding patients? I believe refractory and non-responding are two different patient sets.
An accelerated approval means being able to go to market after successful phase 2 data but still running a phase 3 trial to see whether the success is replicated in a bigger patient population. If not, the drug/treatment is taken off the market.
So not sure how the 2022 commercialization date and an AA trial play out with OncoSec. Would be interested in hearing your thoughts. Thanks.
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