Avid Bioservices Inc (CDMO)

[nuke661]

The following is link to a presentation on the design of clinical trials:

Its about 53 minutes long and although it caused me to nod off a few times resulting in my having to replay multiple segments after recovering from the nodding whiplash I found it very informative. I also found it reinforcing/justifying how PPHM has proceeded with their clinical trials.

One thing that can immediately be useful regarding some of today's postings is that it is nonsense (IMO) to say that the PII pancreatic trial was a "failure".

Per the information provided in this video, it is quite normal to see a failure of of primary outcome for PII trials. However, it is also normal to have expectations that the PII trials are not only for providing justification of proceeding to later stage trials based on the chosen primary outcome but are also pursued to generate indications of other promising avenues to explore.

Per the video, these other promising avenues are quite frequently based on sub-group analysis of trial results, which is exactly what PPHM is broadcasting it has seen in the pancreatic PII trials.

The findings of our sub-group analysis are most likely significant based on ASCO accepting a presentation to discuss this trial. Doesn't make much sense to accept an abstract to say we there is nothing good to offer for the treatment of this disease.

I use the following HYPOTHETICAL example to say it is nonsense to state the only criteria for the trial to be successful is to meet its primary outcome. Start with our pancreatic trial results; yes the primary outcome was not justification alone to pursue this drug in futher trials of pancreatic cancer. BUT, what if the sub-group analysis shows complete responses for less sick and progressed pancreatic cancer patients. What if this avenue is explored and it is found that one of the very most deadly cancers with very very low survival rates all of a sudden has a 80% or greater longer than 5 year survival probability? I would call the trial a fantastic success for generating the promising data that was followed up on to achieve this final result.

We have promising sub-group analysis and we will see what it is at ASCO. I say it only makes sense to withhold the final judgement on success or failure should only be gauged on the information provided at ASCO. To say it is a failure at this juncture is nonsense.