Fundamentals
- Cash
whats the cash runway, FCF?
- Debt
debt/obligations (royalty or milestone)
- Dillution
planned capital raises (Form 3)?
- Trades
recent SEC Form 4, 144, 13F, NP?
- Holders
institution, ETF, insider, retail?
Company
- Management
CEO, CFO track record?
- Corporate Strategy
multiple drugs?
- Transparency
IR communication clear, frequently, consistently with quality data?
- Partnership, M&A
strategic partnerships or buyout rumors?
- history
scandals, clinical holds, crl, trial terminations, withdrawals?
Drug
- product
indication, moa, PD, PK, Toxicity
- Study design
Randomized, double-blind, controlled?
- Comparison
placebo or SoC?
- Treatment
dosing, multiple treatments?
- Patients
how many and which biomarkers?
- SAP
trial rules?
- PE
p-value, CI, effect size, CR rate?
- SE
alpha-controlled? any SE left out? any post-hoc results?
- Relevance
Clinical and statistical meaningful?
- HR, RR
cohorts show similar treatment effects?
- Sensitivity analyses
crossover, dropout data?
- Adverse event
AE, SAE, discontinuations?
- Class effects
AE normal for the indication?
- Black-box
warnings, contraindications, REMS?
- NNT, NNH
benefit/harm ratio?
- Extension Study
follow-up trials, new indications?
- P1/2
consistent efficacy and safety results?
- SoC
whats SoC and can the drug become SoC?
- IP
Substance, indication, formula and how long?
Competitors
- Rivals
Which competing drugs are in late-stage trials, regulatory review, on the market?
- Generics
risk of generics/biosimilars entering the market, already on the market?
Regulatory
- Acceptance
chosen trial endpoints accepted by FDA/EMA?
- Designations
Fast Track, Breakthrough, Orphan, PRIME, Rolling submission?
- Meetings
Pre-NDA, Type-C, End-of-Phase-2 meetings?
- AdCom
outcome of Advisory comitee?
- EMA
Scientific Advice?
- Expansion
plans to file for approval in other markets like EU, Japan, or China?
Market acceptance
- CMC, cGMP
standards fulfilled?
- supply chain
is the supply chain fully prepared to support commercial launch and can it scale?
- Firnal Form
patient-ready form for commercialization?
- Sales, Marketing
sales and marketing team in place, or plans and hires underway to support launch, job openings?
- Acceptance
KOLs, medical societies, and patient groups support the drug’ use?
- CAGR
whats expected market growth?
- Pricing
pricing strategy?
- Peak sales
price × patient number?
- Reimbursement
payers/insurance accept price?
- Burden
frequent hospital visits, monitoring needed?
- Distribution
retail pharmacies, specialty pharmacies, or hospital use only?
- Analysts
rating, revenue, sales projection?