we are going to have to wait for the pre-IND meeting to get anything clarifying what the company has to do.
the 505(b)(2) does call out that animal studies may be needed and particularly for change in administration pathway. its just simply a requirement of the process.
PER did a 6x month tox study and the FDA put them under a clinical hold to do a 9x month study. This is for an indication where there is no approved treatments beyond corticosteroids, and the 9x month study showed exactly what the 6x month study did, the drug was safe.
So, I am suggesting - don't hold your breath the FDA is going to make what we perceive to be a reasonable decision on whether or not an animal study is needed and what it needs to show, how long etc.
There is a risk Phase 1 study is needed...and then maybe no P2, P3.
now, i hold much hope that what was demonstrated in Australia can be used in lieu of a Phase 1 study AND the animal study is short and on easy animals to get a hold of (mice). But, we wont have an answer ill the company does pre-IND meeting Q1 next year.
(20min delay)