Avid Bioservices Inc (CDMO)

[Thurly]

There are confounding things about this data. For expample, the independent investigators say that bavi had a PFS of 6.7. That's higher than Peregrine's own estimate for the trial and it's higher than the India trial results.

The big question is how did that control arm PFS diverge so much from the historical average? That question, if possible, needs to be answered. Was there an imbalance between the treatment arms?

In the Avastin trial, with 444 patients on the paclitaxel and carboplatin only arm, the PFS was 4.5 months.

If we replicate these numbers in the bavi arm of the 2nd line trial (likely) and if the control arm reverts to the mean (don't know why it's such an outlier here - need to understand this better given the historical data), then the PIIb for 2nd line NSCLC will still be a huge win for Peregrine. Note FTM's observation regarding the ongoing 2nd line trial with docetaxel:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73011869
You can make an interesting story from these statistics.
Let us assume that the ORR, PFS, and MOS for the Bavi
arm of the trial come in at 2.5 standard deviations, on the
positive side, from the means of these 10 phase III trials.
The results would be:
ORR = 14.15%
PFS = 3.7 months
MOS = 9.2 months

These values don't seem too out of line from what we might expect, do they?
The probability that each of these results were due to chance is 0.62%.
That assumes that the results from all trials are normally distributed.

2nd Line is still a huge, unmet need with low ORR (5.5%), PFS (2.5 months) and OS (7.5 months).