Spectral Medical (TSX: EDT) - Late Stage FDA PMA Play.

Spectral Medical (TSX: EDT) - Late Stage FDA PMA Play. Hey everyone, Looking for objective outside perspectives on a stock I've been following closely. Not looking for validation, but curious what everyone's thoughts are on this stock What Spectral does \- Spectral Medical makes PMX (Toraymyxin) — a hemoperfusion device that removes endotoxins from the blood in patients with endotoxic septic shock. Already used in 360,000+ treatments safely in Japan and Europe over 20+ years. No equivalent product exists in the US market. Where they are in the FDA process \- PMA submitted May 29, 2026 \- FDA accepted for substantive review June 25, 2026 \- 100-day meeting completed September 11, 2026 \- FDA did NOT request an additional clinical trial - biggest risk now eliminated \- Company confirmed no material change to regulatory timeline \- Deficiency letter received - but 84% of PMAs since 2020 received one and proceeded normally \- Paradigm Capital analyst Scott McAuley called today's update a positive \- Expected FDA decision: November/December 2026 The clinical data \- Tigris trial published in The Lancet Respiratory Medicine \- 95.3% probability of mortality benefit at 28 days \- 99%+ probability at 90 days \- 95.9% probability at 12 months \- NNT of 7.2 at 12 months - clinically exceptional \- 100% patient follow-up across all 157 enrolled patients The commercial setup \- Exclusive US and Canadian distribution partnership with Vantive \- Vantive owned by Carlyle Group - needs an IPO narrative \- Vantive provides non-dilutive financing - no dilution risk \- PMX fits exclusively on Vantive's PrisMax CRRT platform — razor/razor blade model \- Vantive widely viewed as likely acquirer post-approval \- Multiple insiders recently exercised options and held shares during active FDA review Current valuation \- Trading at $1.26 CAD \- Analyst consensus price target $3.15 CAD \- Strong Buy consensus rating \- Market cap approximately $384M CAD \- 52-week range $1.075 - $1.84 What genuinely concerns me - the bear case \- Stock is actually lower now than when PMA was submitted May 29th despite uniformly positive news flow \- Every major catalyst - submission, 12-month data, FDA acceptance, 100-day meeting - has resulted in flat to minimal price action \- CEO exercised and sold to cover taxes in August - optics weren't great regardless of explanation \- 157 patient trial is relatively small by some FDA standards \- Deficiency letter specifics not disclosed - unknown what testing is required \- Thinly traded TSX stock averaging 50k shares daily - virtually invisible to US institutional investors \- No NASDAQ listing limiting US investor access significantly \- FDA clock stops are possible - Toray manufacturing inspection in Japan adds complexity My specific questions \- Does the consistent flat price action on positive catalysts concern you or do you read it as a static shareholder base rather than a negative signal? \- Anyone with medical device PMA experience have a view on deficiency letter resolution timelines? \- How do you think about the Vantive acquisition thesis - pre or post approval and at what price? \- Is the small trial size of 157 patients a genuine FDA concern given the Bayesian framework and 100% follow-up? Thanks again!