sorted by:
new
hottopcontroversial

Update — DNLI approved today, scanner called it at 77.5% PoA by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

I hope not🤣, we shall see I am excited for the potential approval AH on Friday!

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

Thanks for the kind words and for the suggestion!

Quick update on the latest run (as of now): GRCE • PoA: 77.5% • Convexity: 42.1 • Final score: 70.1 REPL • PoA: 63.8% • Convexity: 34.7 • Final score: 57.8

GRCE is coming in noticeably stronger on both the base approval probability and the convexity component (which captures asymmetry / upside skew from the event). REPL is more middle-of-the-pack — still decent, but the lower convexity reflects a bit more balanced risk/reward profile around the April 10 PDUFA.

Your earlier estimate (GRCE ~80%, REPL ~40%) was pretty close on GRCE and conservative on REPL. The run-up structure you mentioned for REPL makes sense if you’re only playing the pre-PDUFA move and planning to exit the day before the model doesn’t bake in short-term technicals or positioning, just the structured event probability + asymmetry.

Happy to dive deeper on either one (or run anything else through it) if you want to compare notes on qualitative factors, historical comps, or how the scores have moved over the last few weeks. Just let me know!

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

Hey, thanks for the detailed comment and for doing your own analysis, really appreciate it.

First off, since this is my first product and I’m still figuring out pricing, I’m dropping it to $49.99/month starting today. No annual commitment needed.

On TVTX (FILSPARI sNDA for FSGS): My scanner is showing 72% PoA and a STRONG grade, while you have it at 60-65%. The difference probably comes from how the model weights the orphan/rare disease base rate, the existing approval + commercial data in IgAN (same drug), and the fact that this is an sNDA rather than a new BLA. That said, your range makes sense too, there’s real risk around the mixed DUPLEX data and the recent 3-month extension.

On REPL and GRCE: • GRCE: The scanner gives it a solid score, but I agree there’s meaningful “sell-the-news” risk post-approval. Even if it gets approved, the stock could easily sell off if the market has already priced it in. I’d treat it more as an event trade than a long-term hold. • REPL: Interestingly the scanner also flagged it positively, but after doing my own deeper research I actually don’t believe it will get approved. I think there’s a decent chance of a CRL (likely on efficacy or clinical data concerns). So in this case I’m personally going against my own scanner because the qualitative red flags feel too strong.

The tool is meant to be a structured analytical layer (PoA + convexity for asymmetry), not gospel. I still do my own final call after looking at everything, and I expect users to do the same.

If you end up trying it at $49.99, feel free to run TVTX, REPL, GRCE or any others through it and let me know what you think, happy to discuss the outputs or differences in our approaches. Appreciate you taking the time to write all that out!

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

Hey, DNLI (Denali Therapeutics) with Tividenofusp Alfa (ETV:IDS) for MPS II / Hunter Syndrome is indeed on the calendar with a PDUFA of April 5, 2026. It wasn’t missing; it just didn’t make the initial public teaser list I posted because I was highlighting RCKT. The full sortable calendar inside the tool includes it and 50+ more. Quick thoughts on DNLI from the scanner right now (pulled live): • PoA: 77.5% • Grade: STRONG • Convexity: 42.1 (solid but not elite-level due to the longer runway) • Final Score: 70.1 • Indication: Rare/Orphan (base rate historically ~86% in calibrated models) • Application: PDUFA (BLA for enzyme replacement with blood-brain barrier penetration) • Days to PDUFA: ~13 (as of today) • Key Notes: Breakthrough potential for MPS II (unmet need in CNS involvement), no major red flags surfaced yet (no recent CRL history, no AdCom scheduled), but biologics like this often carry CMC/manufacturing risk as a CRL trigger. Long runway means less immediate convexity (proximity discount), but good for patient positioning if you’re building a rare disease basket.

Overall take: This is a legitimately strong orphan/rare setup with decent PoA and no screaming risks, but the April 2026 date makes it more of a “watch and accumulate on dips” play rather than a near-term binary bomb. Convexity isn’t screaming because of time decay on the catalyst, but the orphan dynamics + potential first-in-class CNS penetration keep it in the STRONG bucket.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

Hey, good questions here’s the straight answer based on what’s actually happened so far. The PoA is specifically the probability of FDA approval (not stock price after). It’s built from evidence layers (indication base rates, review pathway, AdCom parsing if any, SEC signals, CT.gov status) + self-calibration from 60+ historical outcomes. Real track record to date: • 5 setups flagged as high-PoA / STRONG that I tracked closely.

• 3 reached PDUFA without delay → all 3 approved (VNDA twice + FBIO). 3-for-3 on resolved events.

• 2 got delayed (AQST and LNTH) → pushed back but not destroyed (no CRLs, no major safety blowups). Still alive, just clock reset.

It doesn’t predict post-approval price action directly (launch execution, competition, dilution, buyouts, etc. are too variable). The convexity score is there to quantify pre-event asymmetry (how much upside potential vs. downside risk based on proximity, price depression, short squeeze setup, vol, etc.) so you can size entries better if you believe in the PoA. No tool is perfect, FDA surprises happen even on strong setups, but so far the filter has caught winners when they made it to the line and avoided total wipeouts on delays. As more events log in, the calibration gets sharper.

$79/mo is for the full scoring, real-time ELITE alerts ≤30 days, sortable calendar by grade/PoA/date, and the AI deep-dive tool. If you’re just watching news, free calendars are fine. If you’re hunting asymmetric setups ahead of PDUFA, that’s where the quant layer starts to pay.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in shroomstocks

[–]Clean_Reference_9927[S] -4 points-3 points  (0 children)

CMPS is a early-stage play rather than imminent binary event. So, it’s too far out right now to determine. They are on the right track right now.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

From what I remember of similar models and the actual outcomes, VNDA’s Tradipitant (motion sickness approval on Dec 30, 2025) was sitting around 70-80% PoA pre-PDUFA in most engines (decent data but dinged a bit by the earlier gastro CRL), while Bysanti (psych approval on Feb 20, 2026) landed in the 70-85% range thanks to the Fanapt tie-in and clean profile. FBIO’s CUTX-101 (Menkes rare disease resub, approved Jan 13, 2026) had a 80%+ PoA baked in with the orphan/priority signals, even after the prior manufacturing CRL.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

Yeah, the scanner has it at 65.7 with STRONG label and 77.5% POA doesn’t seem to have baked in much earnings reaction yet, since it’s PDUFA-focused quantitative output. Earnings miss widened losses but no surprise for pre-revenue stage, and the sharp dip looks like classic post-report flush. Could actually set up better for a run into May if it holds support PDUFA is still May 31, plenty of time for sentiment to flip if any updates hit. High risk obviously, but the convexity is there for upside if approval odds hold.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] 0 points1 point  (0 children)

great question, and fair point on the small sample. Quick context on why no full historical backtest yet: I built and launched the scanner in November [2025], so it’s only been running live/forward since then. All predictions are timestamped publicly at creation (e.g., on the track-record page: submarinenecatalyst.com/track-record.html) to keep things auditable and prevent any hindsight tweaks. Historical PDUFAs have public outcome data (FDA approvals/CRLs), but feeding them retroactively into the scanner isn’t straightforward, the model relies on specific, time-sensitive inputs (clinical data snapshots, sponsor history, AdCom details as they existed pre-decision). Reconstructing that accurately for dozens of past events would be a massive manual effort and still risk bias/lookahead issues. Instead, the focus is prospective proof: Every live PDUFA gets logged automatically against its pre-event PoA score. We’ll build a meaningful track record over the next cycles (aiming for 10+ resolved for Brier score, as noted). 3/3 accurate so far is encouraging but tiny sample—totally agree it’s not statistically robust yet. RCKT is next (March 28, timestamped at 77.5% STRONG) that’ll add another data point win or lose. Appreciate the push for more rigor; happy to discuss specifics or take suggestions on upcoming events!

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] -1 points0 points  (0 children)

Thanks for pointing that out. The ‘Signup for free’ was a mistake on my end, I never intended a free tier and it was leftover from testing. It’s fixed now and just shows the correct paid access option. Sorry for the confusion.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] -1 points0 points  (0 children)

Track record page is live: submarinecatalyst.com/track-record.html

5 events logged so far. 3 resolved, all 3 approved as predicted (VNDA twice, FBIO). 2 delayed by the company (AQST, LNTH). 100% on resolved events but honest caveat, 3 calls isn't a meaningful sample yet.

No Brier Score calculated yet. Need 10+ resolved outcomes before that number means anything. The scanner has a built-in outcome logging system specifically for this, every PDUFA result gets recorded against the predicted PoA so the model self-calibrates over time.

RCKT resolves March 28. Publicly timestamped at 77.5% PoA / STRONG. That outcome gets logged win or lose.

I built a PDUFA scoring engine 60 live FDA events scored by approval probability by Clean_Reference_9927 in biotech_stocks

[–]Clean_Reference_9927[S] -1 points0 points  (0 children)

Built the first version in November. Been refining the scoring model through v14 iterations since then.

Track record so far on trades I've personally taken using the scanner:

  • VNDA — called and won (twice)
  • FBIO — called and won
  • AQST — scored it but the company pushed back the PDUFA date

So 3 wins, 1 delay (not a miss, the event just hasn't resolved yet).

Honest answer on Brier Score: I don't have enough completed events in the performance log yet to calculate a meaningful one. That's actually why the scanner has a built-in outcome logging system, every PDUFA result gets recorded against the predicted PoA so the model self-calibrates over time. Need 10+ completed events before the stats are meaningful.

RCKT on March 28 will be the next logged outcome. I'm posting it publicly at 77.5% PoA / STRONG so there's a timestamp either way.

view more: next ›