Clarification of the distinction bb213 is an expanded lung inflammation programthat replaces just pursuing an EUA for only ARDS patients with Covid19.
Its not this instead of that - its lets broaden the terms of reference / definition and get this underway asap with the much broader patient application to multiple inflammatory related diseases that this potential medication will treat / alleviate.
Following the meeting with FDA, Incannex will combine its ARDS/SAARDS and pulmonary neutrophilia
(COPD, asthma, and bronchitis) development activities into a common project and IND, which Incannex
will refer to as its lung inflammation program herein.
The expanded lung inflammation development program contrasts with the former plan to pursue an
Emergency Use Authorisation (‘EUA’) IND for only ARDS patients with COVID-19.Combining the
programs into a single IND submission markedly increases the patient cohort to include those with
bronchitis, asthma, COPD, SAARDS, ARDS and COVID-19 ARDS; increasing the scope and economic
potential of the program.
See the green bb123 - combine the programs ....its an endorsement of what is potentially on the table here from IHL, as recognised by the pre eminent authoritative regulatory organisation in the US. ...thats my read if it assists you interpretation in any way.
Approval has huge positive implications for the company going forward from this point IMO
just my own opinions as always and open for close scrutiny as always
highlighting by for emphasis only
Consolidation around 27c expected before the next leg up IMO -
GLA
