Avid Bioservices Inc (CDMO)

[entdoc]

The company owes stockholders an immediate explanation in terms that everyone can understand about exactly what the problem is, and what the potential ramifications are. The press release tells me nothing about the problem details. Did the control arm get Bavi? Did the Bavi arm get placebo? How many trial sites? All/some? Basic statistical savvy would alert management to a problem if one or two sites were outlyers. Or were the groups not properly stratified by severity of disease. And, as a couple here have asked, what about the patients who are living longer who didn't know which they were/are getting? Most likely, nobody knows for certain who got which, placebo or Bavi, and the trial will have to be run again. The incredible 800 pound gorilla in the room is not the glitch but the patients who are survivers to date. If nothing else we need to know if these are patients with less severe disease going into the trial, and I doubt that is the case. If the glitch only involves this one trial we will soon have some information on pancreas and liver trials. Wow, just when past credibility issues were being forgotten. Stuff happens. This does not appear to be a reflection on PPHM ethic, but rather on choice of the company charged with encrypting and tracking the blinded protocol in the clinical trial. Amazing.