Avid Bioservices Inc (CDMO)

[cjgaddy]

Re: potential AA in 2L/NSCLC, suggest everyone take a re-look at ALL the numbers on 8-15-12 Slide14 (ORR% PFS, and MOS – for both Bavi arms in the ongoing randomized trial, and compare to those #’s for the prev-approved drugs in this indication, Taxotere=docetaxel, Altima=pemetrexed, and Tarceva=erlotinib).
Then, pls. take a peak at Slide 15 while you're at it.
Once you’ve really absorbed all of the #’s, you can go back to your regularly-scheduled program on AA possibilities.

8-15-12: CEO Steve King's 29min. talk at Wedbush/NYC http://tinyurl.com/8mhrtld


S.King/Slide14 8-15-12: “As of a (2nd-Line NSCLC) data cut at the end of April, we were able to analyze the data – the IDMC recommended, based on the maturity of the ORR’s, to unblind the study in the middle of May, and we reported results on 5-21-12 [ http://tinyurl.com/73aeyxj ]. A few things have really stood out about this study, the 1st being that the CTL-arm really behaved itself wonderfully, right in alignment with prior results with Docetaxel alone from an historical perspective, with 8% TRR, 3 mos PFS, and less than 6 mos. MOS – the ctl-arm is right where we expected going into the designing of the study. The other thing that has stood out is the fact that both of the Bavi arms are actually right in alignment with each other, with approx. a doubling of TRR’s (ORR%), 40-50% increase in PFS, and again, both of those data points were mature at the time of unblinding. What is most exciting about the results is the fact that when we unblinded, we had already well-surpassed the MOS point for the control arm at less than 6 mos., and again, that was as of the end of April. As we’re sitting here today, we have still not reached the # of events for MOS in either of the Bavituximab arms – and, in fact, we still have patients that are on treatments. So, clearly we’re seeing a very nice separation with regards to survival between the ctl-arm and both Bavi arms, which continue to perform very equally.”
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SK/Slide15: “We view 2nd-Liine NSCLC as a significant market opportunity…This is a disease in which there is a very high unmet medical need, with < 3mos PFS, and MOS of only 5-8 mos. historically.”