Why would they do this? They are just about done wrapping up their original
phase 2 study and then out of the clear blue they announce a supplemental
phase 2, including biopsies, to find out exactly what is going on under the
surface of the skin. Why would they do this?Why would they invest millions
of dollars into a supplemental phase 2 if they didn’t see positive results
from the original phase 2, which is almost finished?
I can only think of 2 possibilities:
They see positive results from their original phase 2 study so they decided
to do a supplemental phase 2 thinking that they might get enough data from it
that combined with the original phase 2 study and phase 1 study the FDA
might let them put their drug, SM04554, into the marketplace after both phase
2 studies are complete. Keep in mind that the new 21st Century Cures act
allows for “groundbreaking” drugs to come to market after phase 2 trials are
complete if the FDA is agreeable.
They see no positive results from SM04554 and they want to examine below
the skin to find out if SM04554 is having any affect at all below the skin.
But would Samumed use the FDA system to go on a fishing expiation like this
if Samumed saw no new hair growth during the original phase 2 study?