Avid Bioservices Inc (CDMO)

[Protector]

golfho, without wine the following about your PPHM post :)

1) Avid II extension with 2x2000L reactors is for SURE an extension of an existing factory and will fall under the bi-yearly FDA inspection and will not need a separate cGMP certification.

"The planned installation of MilliporeSigma's Mobius® 2000-liter bioreactors opens new opportunities for current and future Avid customers who require greater manufacturing capacity," King added. "We have already secured customer commitments for the 2,000-liter capacity as soon as it is installed in our Myford facility and believe the advanced technology it offers will be a key factor in continuing to grow our Contract Development and Manufacturing Organization business."

2) Avid III (in its current location in the same building NEXT TO Avid II) might or might NOT need such new cGMP certification. IMO all depend on if this is perceived as a FULLY NEW facility (then it will need new certification) or whether it is seen as Steriods :) for AVid III in which case it is an extension and might fall under the bi-annual inspection and only need approvals for the start-up of new batch lines. I kind of hope on some comments of MassH on the subject.

3) I agree that selling shares was the way to go to fund Avid II+ and Avid III. We know loans are to risky as per their loan terms and the disabling of the poison pill who's mechanism is based on issuing shares which would be forbidden then.

4) As for

3 – Exosome technology and the POC. I don’t recall where I read it but a while back I remember someone posting a second university that was investigating the use of PPHM’s Exosome assay for another cancer type. That implied to me that PPHM is looking to have independent verification from several un-affiliated peers to confirm the POC…Adding value to the technology.

Personally I have no such recollection BUT I do know that CEO King said in an annual that after the first prove of concept and the related peer-reviewed publication PPHM would do OTHER such POCs BUT...with a partner. I do NOT know if this is still the current situation or if any academic instance is working on another case. One more would certainly not harm but PPHM needs, IMO, take into account what a potential partner may like best: Be part of the POC design or have them before any partnership.

5) Bavituximab is now mentioned more and more compared to earlier just PS-targeting. Yesterday hutschi posted another one where Bavituximab was mentioned. But indeed more importantly the pre-clinical, clinical, in-ex-vivo, lab-research etc all together provides a solid base of evidence that bavituximab without any doubt conditions the tumour environment in a favourable way increasing the results and the number % responders greatly. Even MORE IMPORTANTLY is that it are world renowned Scientists in the field that recongnize this such as Dr. Antonia (Moffit), Dr. Wolchok (MSK), Dr. Gabrilovich (Wistar), Dr. Birge (Rutger) and many others now including Duke and Anderson and of course our UTSW Lab of Dr. Brekken (+ex-Dr Thorpe) combined who for sure have done the most of the groundbreaking work.