Biotech Values

[iwfal]

It seems tome that a company like TOCA (Tocagen) could benefit greatly from a policy change like this. Comments?

Without more technical clarity it is impossible to tell where Gottlieb is going to draw the line. But part of the reason this has not been standard practice before is that it is hard to draw a bright white line in this particular spot. Lots of subjective factors come into play. Eg:

1) is the OS data from an ITT RCT? (Both ITT and RCT are individually very important)

2) how many trial centers? (Trials from just one or two centers are notoriously unreliable)

3) does it involve messy decisions or skills like resection (which can vary wildly depending on dr etc)

4) how strong is the p value? (clearly p=0.04 is unlikely to be adequate, p=0.0000001 indicates likely repeatability, but in between will vary depending on 1 thru 3 above, which is very subjective)


As for TOCA, their phase 1 data doesn't look good at all on either 1 or 3. So wouldn't give high odds at all for approval based upon the phase 1.