Enzolytics Inc (ENZC)

[foxi]

ITV-1 in Africa was supposed to happen in late March or early April. That morphed into "as soon as possible" in the August 22 PR. Now they're saying Africa can't even begin until all toxicology studies are completed.

Do we know if they have actually started the repeat dose toxicity study? The 10/5 PR only says they're "planning" it.

The ITV-1 therapeutic has succeeded in the clinical investigation earlier, and the Company is planning additional trials [...]

[...] the ITV-1 therapeutic will be provided to the Central and Eastern regions of Africa once all toxicology study phases are completed.

ENZC PR from 10/5

The reason it's a question is it took ENZC from January to October to do the initial toxicology study, afaik with no explanation for the delay. That's typically a few days to a few weeks process if it's a first phase animal study like what's described here: https://pacificbiolabs.com/preclinical-tests-timeline

Now there's a 28-day repeat dose toxicity study in the mix, and possibly additional phases. (Though hopefully no surprises since it sounds like ITV-1 is passing the tests easily at maximum dose.) After that, surely need additional time for toxicology results signoff, prepare paperwork for human trials, start the EMA approval process, and ship ITV-1 to hospitals.

I don't see Africa happening this year, and I hope they don't drag their feet with the toxicology phases! A run in November might help offset this year's tax-loss harvesting.


Why do you figure the second week of November for the audit timeline?


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