Recent content by be6z

I don’t think this suggests any real issue. From my understanding, seed funding is quite common for early-stage medical companies, especially when they’re preparing for FDA approval. Larger companies usually wait until the 510(k) is at least submitted before getting involved. They’re trying to...

I agree with almost everything you said, but why do you think it will take 5 years? Maybe I’m just overly hopeful, but I believe that in about 16 months they’ll have the device ready for FDA submission, and it will be submitted shortly after, in line with their more optimistic timeline. I had...

The timeline shown in the presentation was only indicative. Jon mentioned that a lot of work has already been done to get the device ready for FDA application, but there’s still much more to do. I can’t tell which years correspond to each first or second half, but the general idea is that there...

Out of interest, do you think there are any concerns with the study that may make them have to do additional studies, or would you normally expect this sort of study results to be sufficient for approval, but it may take a while to tick all the boxes?

Amazing, thanks so much for your work on your reports. Dr. Shore's Phase 2 results sounds really promising! Appreciate I haven't been suffering for long and hopefully my tinnitus will go or get better, but in case it doesn't, the idea that something with proven results is making its way is...

That was my interpretation for #1 too but my main takeaway is a significant reduction in loudness. A question was asked to Dr. Shore "What about people with extremely bothersome tinnitus? Her view is that if we can reduce tinnitus loudness by 75% it should help the people who are most bothered."...

Some information on the Phase 2 results were mentioned in Dr Shore's presentation today (thanks @Hazel!) and there was a cumulative decrease in loudness of 6 dB by week 6 (50% reduction) and 12 dB by week 12 (75% reduction). I look forward to seeing the results in full. As someone who has...