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!