For Standard Drug development this is the process, and it is a very long and perilous journey but if successful the pay off is substantial.
Key points that make Incannex very interesting and quite unique are that the Board has chosen to pursue target total addressable markets in excess of $1billion per year which helps the risk/reward ratio. On the General Thread there is a rough future Share Price calculatation for Incannex vs Cochlear based on hypothetical sales of IHL-42X for OSA.
Each of the targeted areas are unmet or under served by current pharmacological treatments and are using existing pharmaceutical approved drugs but just in combination which is of much more significance as the design of each separate trial is to pursue the expedited 505 2 B FDA approval process.
In addition to this Incannex are utilise Camargo (Now called Premier Consulting) to facilitate all discussions with the FDA. In last year's PING Pre IND meeting IHL675A was confirmed to qualify for this and fingers crossed the meeting on 11th May will confirm the same for IHL-42X. This will shave years off standard development timeframes.
It is no accident that IHL-42X contains Dronabinol and IHL-675A used Epidiolex.
IHL Price at posting:
38.0¢ Sentiment: Buy Disclosure: Held
