Replies to post #160231 on Biotech Values

[DewDiligence]

Is there any qualitative difference between a company-sponsored study vs one sponsored by the NCI?

There is no general answer, IMO; rather, each case has to be examined on its own merits.

If the NCI is sponsoring a study, does that imply some sense that the study is less hopeless (or more hopeful)?

Such an assertion is often made by longs on biotech message boards, but it has no basis in fact as far as I know.

What percent of company sponsored trials go from phase II to phase III vs. NCI sponsored trials?

Phase-transition probabilities derived from a large study by BIO are shown in #msg-60339665 (chart) and #msg-59909806 (article). I’m not aware of any published bifurcation of these data according to whether a study was company-sponsored vs NCI (or other third party) sponsored.

Does the company supplying the study drug have ready access to the results or are the results the property of NCI?

In general, a company that is merely furnishing the drug to an independent sponsor does not get early access to the results.

Is there any insight as to how the NCI selects drugs to test compared to what an individual company might do?

Someone on this board who has experience working with the NCI is probably better able to answer this question than I am. Regards, Dew

[biomaven0]

The NCI trials are quite a mishmash, as can be seen by this list of "selected" trials:

http://bethesdatrials.cancer.gov/clinical-research/spotlight.aspx

In general, you'll see a mix of trials for older drugs that are no longer on patent (like valproic acid in the list above), early-stage trials of new agents and, for approved drugs, either novel combination or new indications.

If I had to generalize, I'd say if a trial is "obvious" then the sponsor is going to do it (assuming they have the resources). So the NCI trials tend to be more fleshing things out or trying to answer some scientific hypothesis.

The ECOG trials are perhaps more significant from a pure drug development perspective. My impression is they tend to be bigger on average and later stage.

Peter