niklas_anzinger

3 ms·

1.
by niklas_anzinger 8d ago
Is the scheme you describe a risk? Sure. Any new mechanism is, until it has a track record. What I meant by legible: to run it, you'd have to pass FDA's IND review and reporting requirements, IRB review of the Phase 1, and then Mo
2.
by niklas_anzinger 8d ago
Physicians get a pretty good liability shield in the law; is that strong enough against malpractice suits? I don't know, but it hasn't been raised much as a problem relative to the sponsor risk
3.
by niklas_anzinger 8d ago
Are you sure about that? I've not run a phase-1 but I'm often told the CMC is the most gnarly and expensive part of it & its due to requirements, not sponsor choices.
4.
by niklas_anzinger 10d ago
Relative to the federal approval it's pre-market. In Montana, if your treatment is approved by a review board it's in market
5.
by niklas_anzinger 10d ago
Maybe, but if it's GRAS and supplements/non-drug interventions, can't you do it anyway? This law is addressed at products that are regulated as drugs, biologics and medical devices
6.
by niklas_anzinger 10d ago
- Strong demand from biotechs (first approval decision made and public, Parley Neurotech), we're talking several dozens with $5-300m in funding each - Clinics a bit more lagging, because licensing takes up to 90 days; in a few weeks we
7.
by niklas_anzinger 10d ago
That is the same with all post-market monitoring for drugs. And maybe we can do better because more nimble/startup approach in a small state
8.
by niklas_anzinger 10d ago
I think what you're describing is a risk to the sponsor/biotech, not the physician. It is not a clear-cut question though for the sponsor, because US states regulate medical practice. Federal jurisdiction applies when there is int
9.
by niklas_anzinger 10d ago
Well that'll be a pretty sophisticated scheme, requiring $5-10m funding per phase-1 trial. I suppose that's possible but it would be a highly legible scheme. Also what would be the bad outcomes here? If those drugs end up not bein
10.
Tell HN: An inside view of Montana's new biotech law
34 points by niklas_anzinger 10d ago|21 comments