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Re: WALLnut post# 173468

Friday, 05/03/2024 5:00:10 PM

Friday, May 03, 2024 5:00:10 PM

Post# of 175571
Nice, this came out before the end of the trading day!!

I love their new tagline. It really fits the bill of how Radiogel/IsoPet works.

I recall they estimated the gentoxcity analysis was estimated to last 6 weeks in the Jan update. The date I saw them report the gentoxcity testing itself done was Apr 1 in the 2024 Q1 report. That would mean gentoxcity analysis should wrap up in mid-May.

They have not yet sent the rabbit testing (VX2) report to the independent review group. I would expect that would take at least 2 weeks to review with up to 2 weeks follow up (all that 6 weeks, 2 weeks to wrap up, 2 weeks for review, 2 weeks for back and forth). Putting that out to mid-Jun.

Hydrogel self-life is being finalized so that should get done in May.

So from my math it looks like mid-Jun is probably the most likely for IDE submisssion. With early or late June being when it actually occurs

The schedule has slipped because back in early Mar their estimates made it look like end of April. Not at all surprising and they should be taking extra care and not rushing. They may just consume most of Jun to allow themselves to be able to put the draft aside for a few days before re-re-reviewing it. When you spend so much time/energy on a document you need to distance your self from it on occasion to 'see' it clearly to get the best quality.
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