Arch Therapeutics Inc (ARTH)

[Amatuer17]

I was asking questions about delay in decision and many blamed fda.

Here is the explanation of the delay from the slides today -

“Received and responded to clarifying questions from FDA, as expected
Expected timing for FDA response remains intact: 3-6 months from recent filing”

So FDA responded to ARTH within the defined timeline of 60 days with questions.
Company responded with answers and thus the new timeline of 90 days started again. As such the delay.

It is clear that ARTH did not update SH that they received the queries from fda and so the delay in final decision as such all of us kept on speculating.

All of those who blame FDA - again FDA will try to adhere to agreed milestones and timeline as much as possible.

In biotech - dealing with FDA - no timely news is not a good news.