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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: gary123 who wrote (36028)	6/18/2016 1:46:55 AM
From: drtom1234	Respond to of 63324

When the FDA announce what decision?

To: gary123 who wrote (36028)	6/18/2016 10:56:48 AM
From: weatherproof	Respond to of 63324

Here is an exchange from the recent May cc with the question coming from the WF analyst: "Got it. Great. Thank you so much for the added color there. The – and then I guess just another quick one on the Phase 3 trial plan for triple-negative breast cancer. It sounded like you are entertaining the option of running the trial yourself and is that contingent up on what kind of trial design the FDA and you might decide on in the case of accelerated approval later this month or in a month or so? David Goldenberg Let our CEO answer it, so I can have a good relationship with him. I talk all the funds should beat me up. Cynthia Sullivan So first, we have a spy in place for the protocol for the Phase 3 triple-negative breast cancer patients. And you can visit clinicaltrials.gov and see that protocol layout. We also have scientific advice from the European Regulatory Authorities with regard to that protocol design. So, our plan is to have a partner on board for that Phase 3 study." Obviously, this was unedited. Cindy was talking about and SPA, not "spy", for instance. I don't know. It just seems evasive. Maybe we won't need a ph III for the purposes of market approval, and IMMU is stalling on a partner because of this. Dr G answered another question from this analyst about the ph II enrollment by stating that he was waiting for clarification from the FDA as to whether or not they need more patients to seek AA in the TNBC indication. The implication in that statement is that maybe they do not need more patients. My thinking is that a 2-stage analysis, of whatever type, is a 2-stage analysis! It wasn't designed to be a one-stage analysis and would only stop after the first stage for reasons of futility, meaning that the first stage could not with a reasonable degree of confidence verify the desired outcome. It is good news if the FDA guides IMMU to go to the next stage based on stage 1 results. But we have not seen any news on that front made public, other than conjecture by a broker/analyst. I guess the ph2 could be stopped if the therapeutic was curing patients, or showing some amazing results even if only in a small sample size. We're not seeing that. Not that what we're seeing is bad. It just doesn't seem like it's the stuff that stops a 60 patient trial in the first phase of a ph2 trial So, I have to assume we will need to recruit more patients and Dr G knows this. Again, if that is the case, I believe it is material and we need this to be disclosed by IMMU.