This. Precisely this.
Not only did Bob Clarke do 4 months of stringent due diligence, inspecting every data point imaginable before signing on, but we're all fortunate enough to be able to see the broader picture of why that due diligence resulted in him coming on board.
The strategy and clinical success of Incannex with IHL-42x presents a unique opportunity that was substantially derisked from the moment the combination therapy was formulated. The two compounds have enviable safety profiles and opened the door to the FDA 505(b2) accelerated pathway we are now on. The massive OSA target market was and is ultra ripe and begging for disruption.
GW Pharma and Epidiolex pioneered the first FDA approved cannabinoid, derisking the regulatory hurdle and removing much of the antiquated stigma surrounding cannabis as an illegal substance.
From a safety standpoint, it is quite apparent that the company and the FDA don't have significant concerns. Our blended phase 2/3 pivotal trial design was approved without resistance from the FDA, even though our previous phase 2b proof of concept trial only involved 11 participants. The pivotal trials are designed to run 12 months. By comparison, Aptimed's phase 2 trial involved 294 participants and yet their attempt to run a 6 month phase 3 trial was rejected by the FDA for safety concerns, and their phase 3 design now stipulates 12 months.
And in terms of efficacy, there is no standard of care to beat because there is no approved pharmaceutical drug for the indication yet. The risk to efficacy threshold will almost certainly be met, even if for some bizarre reason our pivotal trials only show half the efficacy our proof of concept trial showed.
So if you piece it all together, IHL-42x probably screamed success to Bob Clarke the same way it did to us.
- An inherently derisked formulation
- An accelerated FDA pathway
- A massive addressable market ripe for disruption
- Very strong efficacy demonstrated
- Ahead of the competition in safety profile and ostensibly somewhat on the timeline to approval
- A corporate team that has executed the process flawlessly to date
His validation is huge considering his epic industry expertise and open doors to major potential acquirers, but we saw what he saw even from our more distant vantage point as retail investors.
All the best
@ime003 and all the rest of us that are keeping our eyes on the prize.
