It seems the FDA has been a major contributing factor to the delays being experienced by Calimmune.
In another forum to which I contribute it has been mentioned that the final patient in cohort one has been dosed. This has take so long because the FDA only allowed Calimmune to screen one patient at a time. Many failed the screening and each attempt took 6 weeks.
Cohort two is now being screened and the FDA has amended the protocol to allow four patients to be screened simultaneously. Hopefully this will allow things to move along much faster now.
This does mean that safety data is probably months away from being released and so it is very unlikely that leaked Calimmune data is responsible for the resurgence in interest in BLT in the US.
BLT Price at posting:
$1.92 Sentiment: None Disclosure: Held
