Replies to post #54709 on Avid Bioservices Inc (CDMO)

[keep_trying]

Moby and Thurly, when PPHM has reported on results from trials, they have consistently highlighted the point that Bavi was "safe and well tolerated". My review of posts and references you exchanged indicates that safety is an ongoing investigation area for all trials. Since PPHM had demonstrated "safe and well tolerated", whether the safety reference is repeated in all citations seems irrelevant. That might be compared with the recent FDA review panel recommendations about Avastin, where overall performance, including safety/side effects were weighed into a post Phase 2 approval assessment.

Thanks for the exchange that affirms that Bavi has been demonstrating that it is safe and well tolerated and that both efficacy and safety are review parameters through various trial stages. I look forward to Bavi demonstrating results in the ongoing Phase 2b trials that can reinforce the India trial results, this time with the double blind trial protocol being practiced in a US trial.

Best wishes and IMO.
KT

[entdoc]

Moby, a slippery slope, thee argument that safety isn't a pivotal part of every trial...and every prescription for that matter. Human safety in prescription medications is never assumed. It is axiomatic that a positive medication effect sometimes correlates with negative effects, and the patient may have to decide if side-effects are worth amelioration of the disease. In the biotech arena almost all safety data is obtained prior to human trials, and the inference of safety is always being reassessed in human use.

[co3aii]

The Phase I is used to see basically that the new drug has no or manageable side effects, dosage, and is less dangerous in effect than the disease it is trying to cure. Once into Phase II any trial is subject to being halted if unexpected safety issues turn up which were not evident in Phase I, same too for Phase III. It is less likely that deleterious side effects will show up in II and III but given the wider population being tested and the varied genetics of the subjects it is something that needs to be looked out for. Of course II and III are efficacy trials with strict controls and if the trial indicates that the drug is not as efficacious as originally thought the trial will be halted.