- Among the 64 FDA-approved drugs, phase 2 trials studied a total of 171 patients in an average of 2 different studies.
- Drugs that went on to fail in phase 3 or get reject by the FDA, however, examined just 69 patients in ~1.2 studies per drug.
- Smaller studies did not let companies get to a final outcome any sooner than larger studies.
These two quotes sum it all up:
"It's not sexy to hang out in phase 2 for three to four years, but that may be best way to develop a drug" - Natenson
"A primary reason for premature advancement to phase 3 is wishful thinking” - Steven Paul of LLY
The results of the Deloitte study also reinforce two tangental laws of biotech investing: