Avid Bioservices Inc (CDMO)

[nuke661]

cheynew,

Again, THANK YOU for your responsible DD and effort in presenting real stuff!

CSM is toast. There is absolutely no comparison between the quality and content of the CSM filing and the PPHM response. (My layman's opinion of course).

This is the section that interest's me the most:

However, Masten encountered serious evidence of vialmislabeling between the placebo and 1 mg/kg groups, use of labels that did not comply with FDA regulations, and evidence of after the fact tampering (PSS 87-96), indicating someone at CSM attempted to undo the "switch" ineffectively. Another huge concern was the post-trial patient serum (blood) study, because the switch of "A" and "B" arms clearly was done by CSM inconsistently. Some patients receiving placebo doses (according to CSM) were also given 1 mg/kg doses for a time. Seven patients dosed with vials labeled as placebo from six clinical sites
around the world demonstrated a significant HACA response, meaning they had an immunoreaction to bavituximab exposure. Twelve of the 40 patients treated with placebo (according to CSM's treatment records) either had a positive HACA response or detectable levels of bavituximab in their serum samples. The audit
revealed no evidence any dosing errors actually occurred at the sites. However, nine different clinical sites around the world were impacted by the dosing errors obviously caused by CSM. (PSS 64) (Masten Decl.; PComp Ex. F).

This section provides the basis for what the perception of the trial results would have been had not the dose switching been discovered. Here is described a control group with various levels of HACA response, not all the same amount and not for the entire control group. Just enough of a percentage to look real with just enough variation especially for a susceptible small trial group of 40. When comparing this data with Bavi treatment groups someone can take the position "Well hells bells, HACA response isn't positive indicatiion of BAVI exposure and BAVI efficay because looky here; the control group has similar responses! Must be something other than Bavi causing this therefore Bavi must be a PLACEBO!

Now correct me if I'm wrong but, weren't we being pelted with postings during the trial that Bavi was just a placebo? Who was posting that stuff? I forgot who they were. Well, not important, the proper authorities will look into this I'm sure.