CLIA waiver is likely 3-6 months or more away at a guess IMO. As Doug suggested in the webinar they will likely have to do clinicals first (I guess this is like testing application protocols to ensure accuracy etc).
As FindMyBroker once posted, it is roughly 6 months for the initial CLIA waiver application, and if more complicated e.g. a testing procedure that is new unlike say covid POC tests, then could take another 6 months with an FDA committee. So if they applied immediately after FDA approval last year (3rd July announcement), and since we didn't get approval by January, I'm assuming up to another 6 months for CLIA waiver, say around June/July 2024. Could be earlier based on 1st April CPT code speculations, but it's just speculation.
This is a "how long is a piece of string" question, and is best asked of Doug at the meeting coming up. He may be able to give ballpark timelines for best and worst case scenario, or at least industry standard timelines, assuming a smooth process.
Don't know if they need to ramp up more staff as part of Hologic, but I would assume most of the money from the recent contract would go to general operations and those staff would now be tasked with the contract at hand as part of the services side of the business. I don't see any need for a CR for the rest of the year IMO, with the current burn rate $2.5m usd per quarter, and with increasing revenue. Also they have an existing loan they could draw upon, as well as extra cash flow if the SP was high enough to tempt some people to convert outstanding options. So all good on the cash side.
I believe that ~$200k usd is for 1 month of sales, with ViraDx likely carrying the large portion of that.
In Doug's words the Hologic agreement is "Transformational" for the company, and 2024 is looking very bright for Lumos. Perhaps all we need is a little magic!
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