The FDA disagrees with you (about the role of the microbiome -- I doubt they have an official opinion on biotech funding). C. Diff. is probably the biggest indication with multiple clinical trials going on to demonstrate the efficacy of full-spectrum fecal microbiota transplants as a therapeutic. Besides that, check out the work of the Allegretti or Borody labs for more human studies about the role of the microbiome in various metabolomic, developmental, and autoimmune diseases.

Fecal transplants are not new science and C. Difficle is just a bacterial infection. The relationship to microbiome science is minimal.

As for the science around the microbiome role in metabolic, developmental and autoimmune disorder is observatory at best. I’ve yet to see a paper that took a human, changed their microbiome and observed X effect (beyond the obvious bacterial infection example).

I'm not quite following how the relationship between microbiome science and an infection of the microbiome is minimal.

But more to your point, using the mg data from their "healthy" population along with the open-label data in the literature seems like a good way to construct RCTs, no? Data from open label studies isn't speculative... it's just not phase 3.

In case you're curious, here are two papers on UC: https://www.ncbi.nlm.nih.gov/pubmed/28214091 and https://www.ncbi.nlm.nih.gov/pubmed/29052237

This is not "Biotech" though, it's "soft healthcare", i.e well-being fluff mainly designed to sidestep any FDA procedure as that would force you to do proper statistical analysis and double-blinded tests.

Hell, it's not even clear that prior to a bunch of bloggers calling them out on it that they were going to seek the input of an IRB.

This. Try to find a single diagnosis, treatment, or illness listed in their claims.

All of VC is frothy right now. It's not that biotech is suddenly more attractive, it's that the tidal wave of cheap money is finally sloshing against the deepest parts of the shoreline.

But also, it's not getting any easier to raise money for a real biotech, where you have to have scientific validation and might hurt people; it's easier to raise money when you're a blockchain biotech, and are promising whizzy vaporware that interacts with customers only in unregulated ways that can't be validated.

Some of the really big rounds have been for therapeutics as well. Denali raised a $250M series A a couple years ago.

There is just a ton of money right now.

Even for companies like uBiome whose business strategy is “we’ll sequence your microbiome and <waves hands around furiously>”

I'd put Denali in the "actually does science" category, though. Certainly more than uBiome. They do have a drug in clinical trials, after all.

Trying desperately not to be bitter as I submit yet another grant to keep my lab going, and where $250K a year is a really pretty successful grant portfolio.

It sounds like we've figured out what'll cause the bubble this time around

I think that's a bit cynical of the current round of bio-based funding. It's not wrong, but it's also not the whole picture.

It's only just started, but there is now a light at the end of the genetic/gene-therapy tunnel. With the approval of the first CAR last year (and it's success at curing children of leukemia), there's now a very real environment to produce valuable inventive biological products that are not just chemicals or antibodies.

Kite and Juno sales for ~$10B each earlier this year has done quite a bit for the field. Vapor always follows the good money, but it's not just that the money is cheap.

Maybe you're right that investors are going a little crazy because there's a whiff of success in the air. But even so, throwing money at a company like uBiome based on the stuff you're talking about is just the usual VC herd-following behavior.