We are all frustrated around the most recent delay, but we should stll be accurate in what was said/promised. Here is the quote from Joe during Q2 call
" I am optimistic that both organizations have the capability to
remediate these issues in the ensuing months ahead, clearing the way for
a potential FDA approval"
That was 7 weeks ago. I am one who believes/hopes the requested changes were small and FDA will approve CMO in next 1-2 months and we will be generating revenue in Q1 '23, but if its A Class 2 CRL and we have to wait for US CMO we still see sales in Q3 '23.
Either is a further delay which is disappointing, but the real question is what is the sales opportunity once we have approval. To that question, I am extremely bullish.
In the meantime, complain all you want, but let's be accurate about the what was said...