Replies to post #261121 on Avid Bioservices Inc (CDMO)

[revenue_monster]

Pphm could quell all the assumptions with some transparency on actual interim results seen in the look in. Why hide if bavi performed as expected?

[Protector]

jbainseky, no, you mixing up again. I NEVER said it on that basis.

I started from the PR/Q-CC and Q&A info and the HISTORICAL STUDIES. Then seeing 9.4, 9.9 and 10.4 months for the control arm I took SK's statement of being at the high end of that. The high end of those 3, to me at least, is 10.4 (because it surely is not 9.4 and 9.9 looks like Middle).

Then I added a margin (because we know they did). The ONE ASSUMPTION/EDUCATED GUESS was: HOW MUCH MARGIN? I theorized that 1.6 months (6 weeks) and added to 10.4 it is 12 months expectation for the control arm. I argued that adding 2 weeks is meaningless and adding to many weeks makes it more difficult for Bavituximab to beat the CTRL arm. Even if it is 4 or 8, 6 is a good estimation and it will not be more then 2 weeks from what they took.

Then again, based on disclosed data by PPHM, I added 2 months on top of the control arm expectation 12+2=14 months. No speculation here. I refered to the Sept 7th 2012 results because by know we know 100% SURE that that was a REAL performance of Bavituximab (with dose switching in its DISADVANTAGE). Hence I said PPHM will have used THOSE RESULTS design SUNRISE in order to tune the EXPECTATIONS (and possibilities) of Bavituximab. We know that PPHM has this awareness of the Spet 7th 2012 results being reliable for SUNRISE trail design, even if they filed more conservative to the FDA, because Brekken confirmed it publicly with Shan and King's permission.

Since the MOS of combined arms in those results was 12.1 mounts on sicker patients with 5.6 months OS SOC Control arm and the current populations has a 10.4 months control arm SOC I said that 10.4-5.6=4.8 months that should be equal improvement in BOTH SUNRISE arms due to healthier patients.

So there is ONLY one assumption/educated guess in there and that is the 6 weeks margin on the high end of the historical control arm data with an error margin of 2 weeks (min 4 and max 8 weeks)

12.1+4.8=16.9 months POTENTIAL for Bavituximab, So 14 MONTHS expectation for the Bavituximab arm in SUNRISE is a quite safe expectation.

So unlike you claim I did NOT start from the statement that PPHM said Bavi performed as expected in SUNRISE. I did say that if it performed as expected, then EXPECTED is 14 months based on the above reasoning which had NOTHING TO DO with that Bavituximab performance statement in SUNRISE.