RE: Odd characters4 Feb 2021 12:02
From a year of reading and posting on this board (and reading the boards of other UK small cap companies with COVID products) there is simply a fundamental understanding of the complex regulatory hoops and processes that must be jumped through in order to produce a commercially viable in vitro diagnostic product.
For the ABC-19 product you then add in the complexity of not only technology transfer to different manufacturing sites (which is obviously completed) but then also the different suppliers involved and managing the interfaces between the different roles in the process. You also need to consider the application of ABC-19, what the results means clinically (and whether people will behave riskily with a positive result) and the political ramifications. I believe we are approaching the end game with this as has been mentioned several times 15th Feb is a key date due to expiy of contract with DHSC who have restricted sales to outside parties. Also important to note they have been an unwitting victim of investigations into dodgy government procurement processes.
I see the antigen test as being a simpler route to market as it just involves Omega and Mologic however what will be absolutely KEY to this product is understanding reporting. COVID-19 is a reportable disease. How do we ensure that positive results are reported by the patient if these tests are approved for home use? How does that reporting even happen? You can't just connect your phone to the NHS servers to transmit into the electronic patient record so there has to be a mechanism here for transmitting of result to a safe location and onward processing.
Its not simply a matter of producing an IVD product (as complex as that process is) its how it integrates within a medical framework, how it impacts politically in this clusterf*ck of a situation and also how peoples behaviour may change depending upon the result.
Im confident i fully believe LFTs have their place (despite my career being based in PCR technologies) and think we are now approaching the end game in terms of integration. once the pipeline is sorted they will absolutely fly off the shelves IMO
DYOR