Healthcare Banking - 52 Rapid-Review Flashcards

Vocabulary flashcards covering 52 rapid-review concepts in healthcare investment banking, including clinical trial phases, regulatory pathways, trial statistics, commercialization, and biopharma financial metrics.

IND

Application that permits human drug trials

Phase I

Clinical trial phase that primarily tests initial safety and dose

Phase II

Clinical trial phase that tests preliminary efficacy

Phase III

Clinical trial phase that typically confirms efficacy at scale

NDA

Application to market a traditional drug

BLA

Application to market a biologic

PDUFA date

FDA's target regulatory action date

Standard FDA review goal

10 months

Priority FDA review goal

6 months

CRL

FDA letter saying an application cannot yet be approved

Fast Track

Designation offering more FDA interaction

Breakthrough Therapy

Designation requiring promising human evidence of major improvement

Accelerated Approval

Pathway allowing earlier approval using predictive endpoints

Priority Review

Designation providing a shorter FDA application review

Rolling Review

Submitting completed NDA sections ahead of the rest

Confirmatory trial

Study verifying benefit after Accelerated Approval

Surrogate endpoint

Measure expected to predict clinical benefit

Primary endpoint

A clinical trial's main planned outcome

Secondary endpoints

Additional outcomes measured in a trial

Efficacy

A drug's ability to produce its intended effect

Tolerability

How well patients can bear a medication

Adverse event

An unfavorable event during a clinical trial

Serious adverse event

Event involving death, life threat, or hospitalization

P-value

Statistic for results under a null hypothesis

Commonly used significance threshold

$$0.05$$

Clinical significance

Whether a benefit actually matters to patients

Statistical significance

Meeting a preset statistical evidence threshold

Randomization

Assigning trial participants by chance

Placebo

An inactive comparison treatment

Double-blind

Trial setup where neither participant nor researcher knows assigned treatment

Benefit-risk assessment

Weighing a drug's benefits against its harms

REMS

FDA safety program requiring extra risk controls

Indication

A drug's FDA-approved treatment use

Formulary

A health plan's list of covered drugs

PBM

Organization managing prescription drug benefits

Prior authorization

Insurer approval required before covering certain drugs

List price

Manufacturer's published drug price

Net price

Manufacturer's price after rebates and discounts

Gross-to-net

Deductions between gross sales and net sales

TAM

Theoretical total drug revenue opportunity

Peak sales

Highest projected annual drug revenue

Market penetration

Share of eligible patients who use the drug

Revenue ramp

Pattern of sales growth after drug launch

Diagnosed patients

People identified as having the disease

Eligible patients

Patients who meet treatment criteria

Patient-year

One full year of treatment exposure

Cash burn

Rate at which a biotech spends cash

Cash runway

Time until a company's cash runs out

Dilution

Reduced ownership percentage after issuing shares

Risk-adjusted NPV

Pipeline valuation weighted by probabilities of success

Patent cliff

Branded drug sales decline after loss of protection

Biosimilar

Comparable follow-on version of a biologic