IMO, we can potentially gauge the likelihood of achieving a successful PLA code reimbursement outcome by generally gauging government and institutional support for LDX and its products.
As mentioned in the above attached, Microbial resistance to antibiotics (AMR) is a real, present and global problem which is being fought on a global scale by pretty much all govt of the world. On a global scale, we can see some significant global support in the fight against AMR.
Additionally, and more locally to the USA, LDX has already garnered support from BARDA (a subset of the USA Gov Department of Health) in the form of a USA $3 million dollar grant to support the LDX CLIA waiver (see images below). A potential total contract value of over USA $ 8 millions dollars is also on offer from BARDA.
IMO, if the USA Govt Department of Health and Human Services (BARDA) is supporting LDX in their work and products, then it is highly likely that other USA government departments and other USA medical institutions will also support LDX in their work and products (for example, IMO it would not make sense for the American Medical Association (AMA) to not provide support if BARDA is already providing support).
So if we can assume that support from one USA government department would translate into support more broadly, then we can assume that the PLA code reimbursement should be successful.
As such, IMO it is highly likely that the PLA code reimbursement will be granted as a contributing measure in the global fight against AMR.
The PLA reimbursement news is due at any moment.
Biomedical Advanced Research and Development Authority (BARDA)
BARDA had awarded LDX USA $2.98 million to support the CLIA waiver, with a potential total of USA $8.25 million available.
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