October 20, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: right to try

5 min read

I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that Garr is the former CEO of Neuralstem (for reference, that company just renamed itself Seneca Biopharma) who now runs a CRO focused on RTT. My SCOTS concerns Two physicians …Read More

6 min read

There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend this piece from Beth Roxland and Elisa A. Hurley on the The PRIM&R blog. What’s the deal? It seems to be a case of what I would call piggybacking …Read More

4 min read

This is Part 2 of my interview with ALS and stem cell advocate, Ted Harada. You can read Part 1 of my talk with Ted on where things stand today with ALS, the FDA, and the Ice Bucket Challenge. What’s your opinion of the “Right To Try” law in Colorado and the concept more generally? It seems to have the potential to speed innovation, but also put patients at risk. How will this be balanced out?  Ted: I am a strong advocate for Right …Read More

5 min read

Is Neuralstem flirting with noncompliance via a Right To Try Law in Colorado? Colorado is an independent-minded state. For example, it is one of only a few states including Washington State with legalized marijuana use. More recently, Colorado passed a new law supported by the ultra-conservative Goldwater Institute, the so-called Right To Try Law. This law allows patients to try experimental, unapproved medical interventions that have completed a Phase 1 clinical trial. Most Phase 1 drugs ultimately fail to be proven safe and effective and Phase …Read More