4 ms·
as in, whenever a CEO does a bunch of press, the co is a good candidate to short? just want to check i'm interpreting correctly
by arikr 10y ago
as in, whenever a CEO does a bunch of press, the co is a good candidate to short? just want to check i'm interpreting correctly
- dnautics 10y agoYeah I was examining long-term puts on the company but decided it was a bad idea since my roommate reminded me Trump's pick for the FDA may scrap phase III altogether (which is a policy I'm not entirely opposed to; PIII tests efficacy not safety, and presumably the drugs could be tested for efficacy by independent NGOs, like what UL does for electronics)
- refurb 10y agoPhase 3 certainly does test safety. It's a bigger trial and safety signals often pop up that didn't in phase 2. Torceptipib is a great example. Phase 2 looked great; phase 3 was stopped due to an increase in deaths.
- dnautics 10y agoIn that sense you could make the argument that 'selling approved drugs on the market' also tests safety. To the point that the FDA has created the pseudo-category "phase 4". Vioxx looked great. Was recalled due to an increase in deaths (which was actually counted in exactly the way you shouldn't, if you've ever read the "how not to run an A/B test").
- rpedela 10y agoPhase 4 recalls are relatively rare thanks to the extra testing in Phase 3. If you removed Phase 3 then the number of recalls would dramatically increase as would the number of deaths.
- raincom 10y agoEven if they abandon PIII, FDA needs efficacy data. So, these companies would stop running underpowered PII trials. Then companies can't use posthoc analysis from PII to submit NDA. So, they need to run another PII with biomarkers identified in the posthoc analysis. There are lots of nanocap biotechs running scams just to advance to PIII after showing minimal efficacy in PII; these companies' execs just wanna milk huge salaries as long as the trials go on.