With only 2 more days to go until we get an approval or a rejection for an IDE from the FDA management and investors must be on pins and needles.
I know that Mr. Joyce has a backup plan if modifications are necessary, but let’s have positive thoughts and hope he can release an announcement of acceptance this Wednesday the 24th!
Once an IDE is secured, more official US based testing can begin! Then what seems fantasy to the skeptics (really? a device that can physically remove viruses and toxins directly from the blood?) will be a reality to the benefit of very sick people. As well as us patient shareholders who helped finance a dream.
The IDE isn't the endgame, but it will be a HUGE advance in testing, credibility, and funding.
IDE reg on FDA website
"Upon receipt of an IDE application, sponsors are notified in writing of the date that FDA received the original application and the IDE number assigned (Receipt of supplements and amendments are not acknowledged).
An IDE application is considered approved 30 days after it has been received by FDA, unless FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16."
It's nice to see the trading activity increase and the share price rise a little in anticipation, but history is not on our side in terms of finding out anything this week, or next or even the one after that. I'm also not sure if the FDA is under the same 30-day window for a response when the resubmission has been in response to issues the FDA brought up on the IDE submission in the first place. This company's MO in regard to less than favorable news is to not release it until a fair amount of time after the fact. So, we'll see. I fervently hope this current IDE submission is accepted and they can get started on the 10-patient trial. Once the safety aspect is established it will be a lot easier to get the okay for other treatment trials.
Though I know better than to be optimistic here, I hold out some hope that there is a definitive agreement announcement pending approval of the IDE, both of which will come out on an 8-K. This is purely speculative though it would make sense from a company financial standpoint. They can try to go it alone overseas, but it is highly likely they will need a partner in the US.