Replies to post #68037 on Avid Bioservices Inc (CDMO)

[cjgaddy]

I’m one who would prefer 1L/NSCLC SURVIVAL announcement to be pushed out even further. Recall, they have already pushed it out twice, going from H2’2012 back in July’12 to H1’2013 today (see below). Assuming what triggers the announcement is 80% deceased, even though MOS (median) has certainly already been determined, pushing out the Bavi+PC arm to the right in the K-M curve (those pts who have survived > MOS months) could very likely generate more curve separation on the right side, and hence an even lower HR Ratio. I’m also one who strongly believes that the HR Ratio ( HR Ratio primer:

) is a much better indication than Median OS, since the HR Ratio measures survival benefit at every point in the K-M curve timeline, not just at the one 50% MOS point in the middle.

As usual, everything X’d!
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Here’s the progression of “Median OS Data” event estimates for Front-Line NSCLC:
• 7-18-2012 Factsheet had Front-Line NSCLC MOS Data est. at H2’2012. “Median OS”
• 9-12-2012 Factsheet chgd. Front-Line NSCLC MOS Data est. to Q4’2012-Q1’2013. “Median OS”
• 1-31-2013 Factsheet chgd. Front-Line NSCLC MOS Data est. to H1’-2013. “Overall Survival”

= = = = = = = = = = = = = = = = = = = = = = = = =
G. Phase IIb Bavi+PC vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory', n=86)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 40 as of 8-12-11)
...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402
...5-7-13: FTM's Table of 20 prev. Ph.3 Trials in 1st-Line NSCLC (ctl=CP), MOS & HR results (Note Avastin improved CP-Only by 19%): http://tinyurl.com/cho7o29
...3-9-12: Topline ORR & PFS Data (Bavi+PC vs.PC-only) http://tinyurl.com/7m9r6ya
…...LOCAL reads: ORR/32%-31% PFS/5.8-4.6mos , CENTRAL reads: ORR/25%-23% PFS/6.7-6.4mos
...12-6-11 Prelim. Data (n=86, 100% Stage IV's) => ORR=39%, PC/alone=25%: http://tinyurl.com/7ph4tty
......Comp. vs. Avastin+PC/Ph3/n=417(74% Stage IV's): ORR=35% (Sandler/E4599/2006 http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884 )
...9-8-11: Enrollment complete. http://tinyurl.com/3vv9zfx
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as
…7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab."
...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl
……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11.