Hey Guys,
This part of todays announcement got my interest.
" Incannex will now expand its discussions with research organisations
and regulators to continue a
clinical and regulatory strategy
and these negotiations are ongoing. In particular, it is anticipated that the US
Food and Drug Administration (‘FDA’) 505(b)(2) new drug application pathway will be applicable to the IBD
indication. This is in addition to the FDA pre-IND submission undertaken for the SAARDS indication, as
detailed in the announcement titled “Positive IHL-675A in vivo results and FDA Pathway” released on the
23rd of November 2020."
"
and these negotiations are ongoing" Can it be implied that IHL are currently negotiating with the FDA?