Newsletter - February 17, 2022
No, FDA Did Not Stop Accepting Clinical Data from China, But…
Last week after FDA persuaded its oncology drug advisory committee to soundly reject a new drug approval application due to it being based on clinical data exclusively from China, some may have been given the impression that FDA no longer accepts clinical data from China for market approval in the US. It is far from it...Read More
Is Digital Medicine Bust? Lessons from Akili
The first company to get FDA approval for an app with medical claims, Akili, had miserable sales of only $377,000 over almost a year with its product. The company’s projection of $500M+ revenue per year seems outlandish in the face of that. Whether it is a financial success or a bust, Akili could become the example for most...Read More
No, FDA Did Not Stop Accepting Clinical Data from China, But…
Last week after FDA persuaded its oncology drug advisory committee to soundly reject a new drug approval application due to it being based on clinical data exclusively from China, some may have been given the impression that FDA no longer accepts clinical data from China for market approval in the US. It is far from it...Read More
Is Digital Medicine Bust? Lessons from Akili
The first company to get FDA approval for an app with medical claims, Akili, had miserable sales of only $377,000 over almost a year with its product. The company’s projection of $500M+ revenue per year seems outlandish in the face of that. Whether it is a financial success or a bust, Akili could become the example for most...Read More
