Cel Sci Corporation (CVM)

[exwannabe]

Any one have any comments about the FDA ruling,

Not really a "ruling", just a policy change.

Years ago, the FDA interrupted the law they operated under to require 2 P3 trials. Around 20(?) years ago they changed this to sometimes require 2 P3 trials and sometimes not.

In cancer, they have not required 2 trials. OTOH, for antibiotics they always wanted to see 2 trials.

This change relaxes that further. All indications will now only need a single P3. This does not change the need to have safety established prior to running a large P3.