Replies to post #279276 on Avid Bioservices Inc (CDMO)

[jakedogman1]

BP can sort thru the "noise" and there is a lot of noise

Keytruda and Opdivo would not have been approved if compared to sunrise control arm of 10.8 mths...

https://jitc.biomedcentral.com/articles/10.1186/s40425-016-0153-x

keytruda....

keynote 001 w/ prior therapy MOS for keytruda was 9.3 mths vs 10.7 mths bavi sunrise all patients...

keynote 010 w/ pdl > 1% MOS was 12.7 mths (note real efficacy was pd1 >50%) and control arm was 8.5 mths vs 10.8 mths for sunrise control arm...

opdivo....

Opdivo mos was 12.2 w/ docetaxel arm 9.4 mths

Bavi...

The ESMO results w/ b2gp1 as biomarker (of which b2gp1 as biomarker is a "joke" and they know it) did well and given the pd1 crowd only addresses about 30% of patients and the current theory is bavi plus pd1 makes the pd1 drugs "better"...

so we find out soon what "biomarkers" predict potential bavi success and the big guns such as fox and gerber are all over it...

i have a feeling some of these trial were designed with "noise" to sort the wheat from the chaff and retail is the chaff

BP knows how to keep score....

[Protector]

geo, I do not agree.

The Breast and Lung Cancer CT's clearly show the improvement due to Bavituximab. I don't care about the control arms or sabotage case because i n the debate if it works it is Bavi's performance compared to TODAY's treatment (SOC) that is important, not compared to ABNORMAL control arms. And there is no doubt about the fact that Bavi, in all mentioned cases, outperform SOC and today's treatment EVEN if it didn't beat its OWN (in-trial) control arm which were abnormal compared to historical and SAME control arms in tests of others (such as Docetaxel vs Opdivo alone).

Furthermore the immune response (no relapse) has been made public by Dr. Stopeck in relation to Breast Cancer and has been observed by at least ONE other party on humans (I think it was in Liver but not sure).

The Bavituximab-Yervoy data in melanoma would be of interest but the fact that we STILL don't have it, IMO, means they are monitoring something in the longer run. That can ONLY be survival because if everyone evented then their is nothing to observe anymore.

Yervoy is FDA approved. On 18 enrolled patients out of the intended 24 (test was stopped because a new SOC was established for melanoma during the trial) at a 30% rate 5.4 patients should be responders in Yervoy's BEST case. If Bavituximab can bring that to 8 (50% improvement on 5.4) that would be a HUGE thing to build on and negotiate.

IMO PPHM knows this ALREADY by know (non-responders would have evented). I think they are monitoring survival and relapse. We are talking about "advanced melanoma", late stage. So responders must easily be detected.

This study is ongoing, but not recruiting participants.

First received: October 29, 2013
Last updated: November 9, 2015
Last verified: October 2015

Estimated Enrollment: 24
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

This is the survival chance if are stage IV (e.g. because you were not treated before and came in late). The years must be counted as of the start of your melanoma. If you are in stage IV you have melanoma for several years already for it to get there.

Stage IV: The 5-year survival rate is about 15% to 20%. The 10-year survival is about 10% to 15%. The outlook is better if the spread is only to distant parts of the skin or distant lymph nodes rather than to other organs, and if the blood level of lactate dehydrogenase (LDH) is normal.

source

The Melanoma was started in April 2014 so today it is 2 years and 6 months active, or 7 months over its "Estimated Primary Completion Date" of March 2016 WHILE we know it didn't enrol till March 2016 but was stopped in Q4/2015 already.

PPHM/CEO King has on the quarterlies said we would get the results of this trial, yet the trial is STILL open but not enrolling. What are they monitoring?