How do changes at the FDA affect us?

Moving RB-190 into the clinic requires a lot of things to be managed just right.

I wrote about the manufacturing process. That continues to go well. We'll be testing the recipes for making tablets of the drug by the end of this month.

The highest hurdles to navigate are those involving the FDA. And as reported, leaders and reviewers are leaving, first through volunteering for early retirement and then by a reduction in force. What will that mean?

When I worked at the FDA, the quality of people and the level of expertise were impressive. But there were not enough people working at the agency. Now with the reduction in employees, there are clearly too few. Amongst the big problems created by these changes are: (1) there won't be enough people for the FDA to respond to submissions by the legal deadlines so processes will slow, (2) with too few people, the agency reviewers won't have enough time to conduct rigorous reviews, meaning there will be errors of oversight and misinterpretation, (3) with too few people, the FDA will not be able to assure the public that a drug or device on the market is safe.... and on the list goes.

It seems gloomy.

For Right Brain Bio, we need to consider any/all options to mitigate this risk of uncertainty about FDA performance. One consideration (that bothers me greatly) is to consider conducting the clinical trials in a foreign country. Because the drug is only approved in the US and Japan, the options are limited. For example, the UK, EU and Canada would not be able to offer the efficient regulatory path the FDA offers for repurposed drugs. And some countries that might be options do not offer the strongest regulatory oversight. Having strong oversight increases the quality of the study, in my opinion, so such countries are not ideal for our trials.

It may be possible to conduct the study in Australia, which is a first-rate place to conduct trials. Personally, I don't look forward to the travel back and forth. And I still prefer to conduct the study in the US. But if the US regulators can't fulfill their obligations and create uncertainty and/or poor performance that would undermine the trial, the only thing to do is explore other options. Mitigating the risk is important.

So I connected with a colleague in Australia to investigate whether this is an option. It's too early to know, and will require investing a bunch of time that would be better spent keeping the current project plan on schedule. But I suppose it is better to have another options rather than the possibility that later this summer instead of facing a high hurdle, running into a brick wall.