Hi Denial,
Agree 100% - your "Blind Spots" are definitely the tip of the iceberg albeit understated IMO.
KNOWN RISKS
1. Clinical Trial Risk - e.g. FDA very unlikely to buy the repurposed idea because existing on market PPS products are oral with different formulations and different mechanisms of action, so to FDA, Zilosul is a new product.
2. Financial Risk - Agree, definitely a $ shortfall already and any further FDA asks will cost more time and more $ millions. Expect big discount in next capital-raise, probably within 12 months.
3. Time Overruns - always happens in late stage trials, always. P3 will be lucky to complete '25 and must add then minimum 6 - 12 months for reg. evaluation and hope nothing further is required. As data on severe OA seems to have been excised from the P2, to establish the minimum effective dose could easily require two, or maybe even 3 dose-ranging studies - all would add time and cost.
4. Personnel Risk - PR hasn't engaged genuine internationally recognized OA leaders so far, getting a bit late
5. Market Risk - big risk when instos head for the door; sooner or later they will and sooner more likely if they get nervous.
UNKNOWN RISKS
1. End Product Labeling - DMOAD claim is heroic; generally requires absolute min. 2 years compelling data vs placebo. P2 Disease modifying is data very weak, at best - big stretch to claim any meaningful DMOAD in P2.
2. Key Man Risk - PR's new team is VERY inexperienced, desperate need for world class OA expertise. PR can't do it all himself.
3. Regulatory Risk - FDA required shift from Mild/Moderate to Moderate/Severe for P3 - Severe OA is a very tough hurdle, will need much, much better data than P2.
4. Corporate Action - Don't know about PR's health, but licensing or M&A at this stage would clearly not support the current Mkt Cap. Would shareholders support big takeover discount?
5. Commercial Approvals - Big pharma will want robust head-on comparative data which P3 does not provide at all. How will PPS fair against Opioids, NSAIDs, Steroids, etc. in the pain market? Anybody's guess?
6. Stakeholders/Competitors - Existing equivalent or better pain relievers already entrenched in world markets at much lower price, some with powerful marketing & much lower prices -+ $2,500 seems fairyland
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