The waiting game continues. Despite the share price decline, there's been no visible change in Prometic's game plan.
Prometic's lead drug already had Orphan Drug and Fast Track designations. To those a Pediatric Disease designation was added. Yet FDA still has not approved Ryplazim, months after widely-expected approval. The product is a natural human protein, recovered from human plasma. Trial results have been excellent. Exceptional, even. Unquestionable efficacy and safety.
Beyond Ryplazim, PBI-4050 and variants show well, and updates on trial results are expected soon.
Some suspicion focuses on possible production problems for Ryplazim. Given Prometic's long experience producing and selling plasminogen to commercial clients via its PPPS process, that would be a surprise. Yet something -- labeling, packaging, who knows? -- is causing delay.
This, when FDA has promised accelerated approvals.
These factors, in combination with a devastating short attack has left Prometic at $CAD 1.43/share, 10 Sept/2017. The principal concern now is that FDA approval will be delayed past January 2018, necessitating another dilutive share issue at a depressed price.
While I'm not here to pump this stock, I'm holding. Barring a major market downturn, the expectation is over $3 CAD by spring 2018. But as we all know, there are risks.
Jim |
