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tntgraham

03/13/20 10:25 PM

#118470 RE: 1234jklm #118468

2 years over already then, sweet. Ready to roll soon

1234jklm

03/13/20 10:28 PM

#118471 RE: 1234jklm #118468

Not necessarily because there are now more cells per cap do perhaps they need to test the very sucvessful new manufactured ciab for stability

I wouldn’t think so but I don’t know.

Not fda required though and only gives an even better credential if it lasts 2 years after being frozen.

Better shelf life is always good but six months will, be fine for the fda.

fraum

03/13/20 10:54 PM

#118473 RE: 1234jklm #118468

Lol. Ok. You must not have read the 10Q then. I didn't say anything about what is and isn't fda required. I repeated what was in the 10Q and it says

We are continuing to work on projects related to the planned IND submission... a container closure integrity test of our clinical trial product that will be conducted over the course of two years, a pyrogenicity test, preparation of the angiography guidelines for implantation of the encapsulated cells for use in the LAPC clinical trial and a two-year stability study of our clinical trial product

So the 10Q says the two year tests are part of IND submission right there in black and white. LOLOLOLOL!!!! For those who can read lol.