bkkrunner - some interesting points. I feel your frustration.
I would have to say, though, that the position of biotechs is not quite so straightforward. While you are correct that there's no impediment to a company providing a running commentary on trial progress, this is a frought endeavour.
Trials are structred to provide a statistacally robust set of final observations, which may not be (usually are not) homogeneous. For example:
- A trial is constructed around 20 participants.
- Participants 1 through 5 go well, with no AE's and some response to the trial drug.
- Particpants 6 through 16, not so good. Moderate AE's and patchy drug response.
- Participants 17 through 20, moderate response to the trial drug and only minor AE's.
Now, the company sponsor that provides an update after dosing particpant 5 would probably be telling the market that everythng looks great.
Then along comes the rest of the trial...
There would likely be a view formed that the company had misled the market with its premature positive update - departing form the trial design before the statistical endpoint was known.
The risk of this type of error is significantly higher in early phase trials where there is no randomisation, control group or double blinding - like ours. There could easily be something about the way participants are being selected, manufacturing, administration, etc. etc. that is later found to have skewed the results - for better or worse.
Sure, this is probably less of an issue with a diagnostic than a medicament, but it's still a live issue that requires careful management.
I've seen this happen and been involved in the ensruing class actions that resulted from information provided - possibly with the best of intentions at the time and maybe due to early excitement - that was subsequently shown to be false.
That's why we have to wait for the full results.
Welcome to the world of biotech!
Cheers
Densy
Expand
