Thanks for the compliment, but believe me there are plenty of astute biotech investors on SI - some that don't post that much, though. In particular, I'm not a scientist, so I have to leach off of people like Rick (who doesn't answer to "Richard", BTW <g>).
The relationship between early Phase II results and final Phase III results is perhaps the key question in long-term biotech investing. Plenty of examples of products that have looked good in Phase II and then crashed and burned in Phase
III, so you can't just blindly extrapolate.
Key issues in considering a Phase II:
1. Is there a reasonable theoretical basis for believing it should work. (Including animal studies).
1. Size of study - bigger is obviously better.
2. What was the patient population? Often early cancer trials are done on people near death's door, which makes judging results in the general cancer population hard. But beware too of trials on carefully selected patients.
2. Was it blinded? Often early Phase II's are not. How much this matters depends a lot on the disease.
4. Was there a sensible dose/response relationship? (Harder to judge for immunological stuff).
5. Side-effect profile compared with what you are treating.
(Cancer treatment, say, is much more tolerant of side effects than is cancer prevention).
6. Was there a subset analysis? ("the left-handed patients did great")
7. Quality of the institution. Foreign trials, fairly or unfairly, are a red flag.
Small biotechs have the tendency to rush the Phase II's and end up with a bad Phase III study. Pharma's have more time and money and so their Phase II's tend to be larger and more predictive of the final outcome.
I haven't studied Mylovenge yet, but at first glance it looks like strong results, albeit in a very small group.
Peter |
