1. Missing MilestonesThe point about missing milestones is important and is one of the two missteps from management. When milestones are missed, they need to be communicated to shareholders. The board during the year did a poor job and this was reflected with the general SP trend down.
The huge options(1.25 million) granted to Scott Williams to promote Invex haven't paid off in my opinion. With Paradigm, Scott's written pieces were fantastic and detailed. But with Invex, he's only produced one note and a bunch of small podcasts. Hopefully, management had the foresight to put in tough vesting conditions because it hasn't reflected in the SP.
On the bright side, I expect that the calibre of Thomas Duthy will do much to enhance shareholder communication. He's already displayed some level of maturity in providing justification for the missed milestones. Let's hope he's part of the answer to improving Invex's communication in the future.
2. Regulatory Interactions
Of course it's with the benefit of hindsight, but I feel the regulatory interactions with the FDA and EMA could have been more thoughtful.
For example, Invex could have onboarded experienced regulatory personnel like Carol Parish before submitting a package to the EMA and FDA. They could have tried harmonising interactions through the EMA-FDA parallel scientific route which may have saved time. Akin to what $PAR.ASX has done with their MPS trial.
Fortunately, they've now got Carol Parish onboard. Their new regulatory strategy is extremely pragmatic - lock in the EMA first. Then push the FDA to harmonise with a Type B meeting. A Type B meeting with the division of neurology allows Invex to play to its strength in clinical expertise. They can wheel out Professor Sinclair, who as we've seen in the Bell Potter presentation, is an impressive top-tier KOL who can powerfully relate a patient experience with the need for new therapies in the IIH indication.
3. The Big Picture
My feeling is that the market has forgotten that direction of two trials came from the division of opthalmology whereas Invex is now repivoting to prosecute headache day with the division of neurology, who has yet to see the scientific package as well as the strong Phase 2 data.
My view is that this new direction resets the stance of the FDA, and gives Invex every chance possible of nailing Phase 3 in just one trial.
It's going to be a long wait, but I look forward to reading back on these posts in 2024 when Invex is hopefully bought out for many multiples of this price.
(20min delay)