Biotech Values

[jq1234]

1. Management gave too aggressive a timeline to satisfy Wall Street's hunger for near-term events.
2. The modeling management did when setting up the trial is flawed.

The first is clearly negative. The second is certainly not positive.

Don't be so sure about the second. Often times, trial was designed/expected conservatively for active arm in a larger trial, assuming worse than result from previous smaller trial, but actual result was trending much closer to previous trial results, thus caused event accural delay. This does happen, but just don't get publicized as much as the cases you listed.

The ultimate conclusion was that we could not say whether the "delay" was positive or negative.

This is probably true in most cases. There are cases where positive can be detected, also cases where negative can be detected. Lots of information are needed/assumed in those cases. There is NO simple universal positive or universal negative as claimed by both sides.

Similar to your example was PARD's picoplatin in SCLC in 2009. I did quite a bit modeling myself, obviously with quite a few assumptions about patient enrollment - management did give update on patient enrollment quite often. My conclusion was the delay in reaching 320 events implied it was unlikely the BSC arm would hold the 14 weeks OS as assumed in trial design. However, the modeling couldn't say whether the trial would succeed or fail. The final OS for pico vs BSC was 20 weeks vs 19 weeks, a failed trial, so the delay was mainly caused by significant increase in OS from BSC arm.