Biotech Values

[poorgradstudent]

>1. The “208”protocol specified that manner in which interim data would be made available to the sponsoring company (GENR) and it specified that the Evizon arms were to be bundled<

Certainly possible. But if the company designed the protocol for the interim analysis (they presumably did with some consultation), then it was a bad mistake or an oversight on their part to create a scenario where they themselves received bundled data. The bundled data isn't very useful, and it would be shocking to know that the company tied its own hands in such a manner.

The other side of this argument is that if you believe the management is bright, then they would have ensured that they receive as much data as possible from an interim analysis. That scenario would suggest that they have the data broken down by dose levels as well.

(They already have data segregated by treatment, so I don't think revealing the results by dose level undermines the masking of the trial in any way.)

>2. GENR did not want to reveal the unbundled data because the data are not great. If this is the case, the company is effectively using the bundling as a smokescreen to hide the data for the individual doses.<

One other possibility here is that the results by dose levels may have revealed something unpleasant or confounding. For example, if your best results are at 20 mg and you see poor results at 10 and 40 mg, that almost suggests that the 20 mg results are a fluke as well. How else, biologically, can you explain that an intermediate dose had an effect while half the dose and double the dose were entirely ineffective?