Adam Feuerstein

Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts

Anand-Srivastava

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of …

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About that Athersys stem cell stroke clinic trial PR…

Athersys

There has been a lot of excitement this week about a press release from stem cell biotech Athersys that reported that treatment of stroke patients with its product MultiStem was associated with a statistically significant improvement at 1-year. This sounds encouraging and the stock has spiked up as a result. However, there are some naysayers …

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Osiris FDA Letter: Trick or Treat?

Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has …

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