Avid Bioservices Inc (CDMO)

[keep_trying]

Wook, yes, my understanding is approval for commercial use starts the patent protection clock.

Note that if a competitor Pharma gets Bavi rights, there is nothing to keep that Pharma from picking up supply of the previous SOC product from third parties, leaving the original but expired patent Pharma at risk of losing their revenue stream. In contrast, if the original Pharma gains Bavi rights, they can continue to collect their Bavi bundled product's revenue stream. This revenue stream acquisition potential also applies to PPHM if PPHM trials show that a going off patent SOC product bundled with Bavi exhibits significant improvements AND the FDA gives PPHM advanced approval or a post Phase 3 Bavi trial, commercial use approval.

The big "if" here is whether Bavi bundled treatment is outperforming SOC sufficient to achieve an FDA approval. That pending NSCLC Bavi trial Median Overall Survival data has good potential for doing just that, bundled with some products that saw expiration of their patent protection. That means that PPHM success demonstration from this trial "lights up" the up for grabs revenue stream scenario I described above.

Now add to the competitive mix that Bavi bundled with other Pharma products is showing indications of efficacy that is on the path to delivering a prospective new Standard of Care. That means that a Pharma that acquires exclusive Bavi rights is positioned to clean sweep the revenue streams of several competing Pharma products. Or if PPHM can plod along going it alone until the FDA gives PPHM Baviroval for treatment of one application (like NSCLC), PPHM can plod along with development acquiring ever increasing resources to usurp the revenue streams for itself.

If this were a chess game, release of the NSCLC trials MOS results would be like PPHM at the negotiating table can place a move that places its opponent into an inevitable "check mate". The Dr. Garnick Chess master is playing multiple games with different Pharma across the table, but this trial result move places all those affected Pharma at risk at the same time.

Does PPHM have the goods? Pharma that signed confidentiality agreements with PPHM likely know where they stand, already. Once Dr. Garnick and the PPHM team executed their multiple trials plan and the NSCLC MOS results became positioned as a critical success deliverable, the ability for Pharma to put off PPHM negotiations was put on a short clock.

Best wishes and IMO.

KT

KT