BMEA – Phase 1/2 Data

Data readouts can be everything from absolutely insane to quietly passing like a fox at night.  A lot of times, traders are reacting to information from the data readout that isn’t necessarily what that study is for.  Anytime data comes out that shows that there is a statistically significant change in the patients taking the meds versus the sugar pills, it’s a big deal.  Especially the first time that data is evident.  Often it comes out in Phase 2, when the real reason for that phase is safety and not efficacy.  However, it is important to note that when Phase 2 comes out, if efficacy tests under desired, but safety is great, that could still drop the stock price.  Even if the company starts on Phase 3 the next week, it is always a headwind when efficacy data is showing early signs of not being satisfactory.

Briefly here are the data readouts that can come and what they talk about:

Phase 1: Purely Safety, smaller sample size of patients.

Phase 2: Safety on a larger sample size, initial efficacy results

Phase 1/2: is a combined study with elements of both phase 1 and phase 2, where the main goal is understanding safety, or sometimes it is done when a drug is being studied as a therapy that combines it with another drug.  The expectation from a Phase 1/2 is that there will be some efficacy data.

Phase 3: Efficacy, Safety, for a large sample size, with predetermined desired outcomes (minimum efficacy rates).