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This announcement was interesting in many ways. I’ll start with my concerns.
rhe company has said for a long time that the dossier of trial evidence has been submitted and its a waiting game. In fact the company advised that it had provided an updated dossier not so long ago. Never has the company tagged the third milestone to real word studies.
now the CEO comes out and states that: “Further published evidence of Cxbladder’s clinical utility is the conclusive milestone required by our Medicare Administrative Contractor (Novitas) for Cxbladder’s inclusion in the LCD” never has the CEO stated that the LCD required additional information.
I’m sure as with anything that the LCD requires a weight of evidence. Real world clinical practice studies would hold much more weight than a trial. I get that, and I’m not a scientist. I do feel that management have not been open about the requirements for LCD inclusion. I would happily stand corrected however this is the first I have seen mentioned the name Novitas mentioned. Assuming this is the firm employed to put forward the application for LCD.
My main concern is, information was disclosed stating that all information that was required had been submitted, never once was there highlighted a need for additional information.
Now for some balance. The positive response to the announcement was good, there was some ok volume and a larger price increase than we have seen for some time.
A real world study showing the efficacy is compelling. We are told this is now a key milestone. I get the feeling that the tone of this announcement is very positive. It seems to me that the LCD could be very close.
The SP action over the coming weeks may be able to show us what the general market thinks however some larger volume will be required.
Even though the last capital raise was at quite low levels, I would suggest. Given the majority has been raised at may multiples of the Curren SP this participating in the CR were likely lowering their initial investment price IMO.
The LCD is key. Closely followed by agreeing the one off payment for the tests already conducted. To be fair the shareholders have been paying to co duct the tests currently. Despite invoicing these operating cash flow has been stumped up by the company shareholders.
it’s a race against the bank account for LCD inclusion vs operating cash flows.
2020 is looking like make or break for PEB. The weight of evidence supports the product and one can not say its better for pairing welfare, reduced cost and less invasive.
