by rss feed | Jul 26, 2023 | cell therapy for COVID, COVID-19, Direct Biologics, ExoFlo, News Feeds, Reviews
From the beginning of the pandemic, I have been mostly skeptical about the idea of cell therapy for COVID including stem cell therapies. However, at the same time, I’ve closely followed the data, especially up until 2022. Now having just had a nasty bout with...
by rss feed | Mar 16, 2023 | Direct Biologics, exosome companies, exosomes, Fact-check, Kimera Labs, News Feeds, Organicell
Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are...
by rss feed | Nov 3, 2022 | Direct Biologics, ExoFlo, FDA, FDA IND, journal club, News Feeds
I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on...
by rss feed | Sep 13, 2022 | Direct Biologics, ExoFlo, FDA, Investigative, Linda Mays McCaul, Michael McCaul, News Feeds, Stephen Hahn
An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021 shortly before he resigned at the...
