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Saturday, February 03, 2018 5:14:11 PM
Their answer matched yours regarding PC: "The retrievability issue is only relevant for chronic conditions like diabetes where the capsules may reside in the body for a long time."
That said, there was another recent post here that referenced a Lohr presentation from ASCO 2017 as saying that in the pre-IND the FDA said they didn't care what happened to them after activation. That does not match with the response I received from Investor Relation. I asked them specifically whether it was discussed with the FDA at the pre-IND, and they mentioned that it was not discussed, and has not been discussed since. So, based on the information I received, it seems that they think it is a non-issue for PC, but it was not discussed at the pre-IND or since. That does not mean it wasn't discussed a long time ago with the FDA, which is what I think Lohr was referencing in that ASCO presentation. (Listening to the clip, I did not hear him say pre-IND), but he certainly did mention that the FDA said...when, where...who knows.
So, if I take that information and use the thing between my ears, I would lean towards it really not being an issue for PC because think about it, does cell retrieval really matter for a death sentence? Investor Relations did say that the cells could be removed if the tumor was being surgically removed. If the tumor is being surgically removed, it's a really good thing for us (well, for those who really want the treatment to succeed...not necessarily everybody on this board). Ideally, it would have been confirmed with the FDA, and maybe it has at some point, but IR says it was not during pre-IND or after.
Since Austrianova had that statement on their website that cells can be retrieved if needed, I did reach out to their contact information, but have not received any response...nor have I ever received a response when reaching out to Austrianova. I'll give it to PMCB, at least they took the time to communicate with me.
I think diabetes is another issue altogether...
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