Yes, pivotal trial will be the last. It depends on how early they start, how quickly they can fill the trial up, and whether or not they keep the trial at 210 days or if the results are good enough and they can reduce it down to 90 days.
This supports my earlier suspicions that they will slightly delay to try to add a bigger cohort for Phase 3 after the severe and age related trials so they can release with all those indications and recruit more easily for a bigger Phase 3 trial.
They said that it will be made available on their website for viewing although not sure if it's available yet as I haven't checked!
I wish I could but my TTTS disqualifies me. My dad however fits the bill perfectly. I think the more people that this forum can get into the trial, the better.
Isn't the fact alone they have stated this expectation a good sign for things to come?
I really don't think filling up the Phase 3 will be of concern; there will be significantly more awareness of the drug by year-end, and the trial will likely be international.
Yeah, I'm planning to apply for Phase 3. I'd be happy to treat one ear until the drug is actually released.
I'd say so... two things of significance happened today:
I was thinking the same, however when I researched it, drops seen in biotech are usually so quick it you can't. So even if you set a stop-loss, it will sell at the market price that can be 60%-90% down and the stop loss goes out the window. It happened to me, thankfully I didn't invest too much but pretty much my whole investment was wiped out. I knew the risks. Investing in biotech can be lucrative... and dangerous.To my fellow-investors... Can you lose "99.8% of money" if you set a stop-limit order? An order to sell automatically when stocks drop below a certain price?
On the one hand, that seems like a logical safety measure to put on your high risk stocks. On the other hand, you still hear horror stories from people who lost everything.
Were they just too lazy to put a stop-limit order? Or does a stop-limit not work when stocks crash (because there is no one to buy?)
I would like to know for sure before it happens
Just remember that the difference between Q4/2021 and Q1/2022 is just 3 months.
I think it probably will be 90 days. They put an emphasis on having the Fast Track status from the FDA.
I think if FX-322 shows to have any clinically meaningful effect on tinnitus for people with acquired SNHL, doctors will be inclined to try it. Also, your high frequencies look a lot like mine. However, mine drops like a stone at 15 kHz and 16 kHz... where most of my tinnitus lives... so there may be a correlation there.
Your extended audiogram only goes up to 12.5 kHz, but the full range of testing in more specialized clinical practice is up to 16 kHz (before standing waves can interfere with reliability of measurement).
I don't know why I haven't thought of this before, but I develop and execute cold outbound marketing campaigns and could very feasibly identify, scrape and email every ENT in the U.S. a 'request' to pay attention to this. Maybe I'll start in my local market as a test. I could do the same to Audiologists for Lenire, Audiologists who drive Teslas and even Tesla owners who have hearing problems. Love me a good customer archetype.I think they are realizing they need to get a lot of momentum going early in the practitioner, patient, and investor space this year.... it needs practitioners and patients primed for treatment well in advance.
Also... a little hype doesn't hurt
If you got your hearing problems from noise then there's a reasonable chance it will help even if you score normal on a standard audiogram.
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