“Are you aware that all of BIEL's utility patents have expired?”
Are you aware that when a company’s FDA - cleared product patent expires, another entity cannot use the existing clearance(s) by simply replicating the product? That they must submit a new application(s) for FDA clearance?
My thoughts about the inherent value of BIEL’s products relative to a buyout has always been based on what the buyer sees as the potential for FUTURE substantial revenues. Additionally, a buyout eliminates the need for any “restart” re FDA clearance(s), which ANY OTHER COMPANY would have to do should they replicate the product. The clearance process is not a nothing burger.
Speculations here are seemingly offered as expert opinion…about “how long” a process would take to complete clearances or whether only one clearance would be needed, speculations about clinical trials and interpretations of them, the NPA/CMS process, coding, the entrenched political machinery and lobbying that is ever present in allopathic medicine. Many speculations… “but, but, buts”…seemingly offered as expert opinion. ALL are subject to variability in what way and how fast things get done depending on WHAT company if any, and especially given their resources, might be interested in BIEL.
Here’s a fact…where BIEL goes, if anywhere, will not be a function of where BIEL has been or is now, but is a function of whether Company “X” sees something in BIEL and sees a source of substantial income.
Company X will have the know-how regarding ANY issues needing resolution, and the army to get it done vs little old BIEL… for the NPA/CMS
Once again, the fact is that neither you, nor I, nor anyone here, knows where this whole thing goes for BIEL via the NPA/CMS, and if it does “Go”, how it will.
But I do know one thing, the cacophony is ever increasing as the days go inch towards 01 January 2025.
There are no experts here. Anyone who thinks they are…should stop pretending.
All imo
