The Hough pill delay really didn't seem to have anything to do with the FDA or the clinical process as a general concept.I heard from @HootOwl Hough Pill's purpose is being redefined (something to do with recovering from cochlear implants I think) for faster approval. OTO-413 seems smiled upon so far with some of the more well read and up to date users on this forum.
I haven't heard much about Pipeline's drug but it has its own thread in this forum (so do the others).
Personally I still can't believe how messed up the process is to get a promising drug from development to the market.
I'm so mind boggled that something like the Hough pill can sit for 5 years collecting dust (before another 5 years+ for trials) that I'm actually thinking about doing work in the pharmaceutical sector to do what I can to change things.
The broken process of what it takes to get a life-changing therapy to the market and the people that need it should be put under a magnifying glass. It makes my stomach churn.
Hough had a previous biotech partner (Otologic Pharmaceutics--a very small player local to Oklahoma and in fact Kopke from Hough is on their board) who didn't push it forward or at least not in the same way. In fact, the drug at some point was tried for other indications like stroke. Oblato, as a multi-national biotech, at least know what they are doing in this regard and if they had partnered with Oblato first, I think the drug could be close to market by now.
It was interesting to listen to the latest Tinnitus Talk Podcast and hear Dr. Thanos describe how he has literally no idea how the process of getting investors/fundraising works and had to hire veterans to figure that out. He didn't even seem to know the basic ideas of it. Which, i suppose makes sense since he's a scientist and not a fundraiser but it seems like the scientists themselves would make the best advocates for funding.
Personally, I think if you wanted to make a difference in this regard, more accessible consultants to small cap biotechs would be a game changer.