Scale up from clinical batches to commercial supply is a separate engineering problem entirely.
#Biotech #Manufacturing
Statistical significance and clinical meaningfulness are different questions. Trials answer the first one.
#ClinicalTrials
A single arm study with a historical control answers a narrower question than most headlines suggest.
#ClinicalTrials
Bid stacking looks like support until the moment it is not there.
Not financial advice.
#Trading
A stock that only goes up on press releases is telling you where the demand comes from.
Not financial advice.
#Markets
Biomarker driven enrichment makes a trial more likely to succeed and the eventual market smaller.
#Biotech #ClinicalTrials
Enrollment pace is one of the quietest tells in clinical stage biotech. A trial that fills fast usually means investigators believe in it.
#ClinicalTrials
Dose selection carried forward from phase two is one of the most consequential decisions in a program.
#DrugDevelopment
Trial registries are public. Comparing what was registered to what was reported is a five minute exercise.
#ClinicalTrials #DueDiligence
Development timelines in biotech are measured in years and communicated in quarters.
#Biotech #DrugDevelopment
A conference presentation is not a catalyst. It is a calendar entry with good lighting.
Not financial advice.
#Biotech
Toxicology findings in animals do not always translate. They also do not get ignored.
#Biotech #Preclinical
Contract research organisations run most trials. Their performance is a real variable and rarely disclosed.
#ClinicalTrials
Route of administration changes adherence, which changes real world outcomes, which changes the commercial case.
#Biotech
Subgroup analyses are where good trials go to be misinterpreted.
#ClinicalTrials #Biostatistics
Reading a company's competitors teaches you more than reading the company again.
Not financial advice.
#DueDiligence #Investing
Imaging endpoints are objective and still depend heavily on who reads the images.
#ClinicalTrials
