I had asked this Q in the last LDX Results presentation. They have no intention of bringing in the AT1 device capacity inhouse (short to midterm, 2-3yra). The Q was answered by the CEO specifically that they continue to work well with AT1 on future supply forecast + increased test stockpile, pending FDA approval.
The LDX 10m capacity increase was mostly aimed for its commercial/OEM manufacturing biz. Inhouse, they have also increased Febdrix strip manufacturing also, pending FDA approval sales growth, based on AT1 platform
Also, a few months go, I had posted details about the IP tie-up between both companies that prohibit/limit LDX from moving away from AT1 integrated device base. It's taken LDX 5-7yrs+ to get the multiple health approvals (with AT1 device platform) across the globe, based of many, many clinical trials....and the FDA app also has the same approach (US trials were done with the integrated device test). And natually LDX cannot manufacture AT1 device inhouse without licensing approval and royalty payments (which is a possibility but it continues the tie-up and not split)
Yes, LDX can certainly plan and implement moving away from AT1's device supply (long term). They will need to do certain clinical trials again, with their own disposable platform or another supplier. The cons for this possibility is that it will take minimum 2yrs to complete new device testing, trials, data submission and approval time for US, Canada, EU, Middle East, Australia geos. Its not small task + they will also lose the integrated device benefits for their test (as there is no supplier globally who still offers such a platform type yet).
So for the mid-term 2-3yr future, I don't consider LDX supply split a serious risk for my investment.
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