Hi mirri, I did a post about the structural complexity and...

Hi mirri, I did a post about the structural complexity and difficulty of replication here:

https://hotcopper.com.au/threads/ann-clarification-of-recent-analyst-report-on-patent-protection.6631844/page-45

The upshot is, PPS is not a single well defined molecule, but a mixture of many slightly different variants of the molecular structure that Mozz posted. This is often the case with natural products - natural synthesis of these kinds of complex polysaccharides does not cleanly produce the exact structure every time, so you wind up with a mixture of closely related structures, not the single canonical structure.

The natural material that is recovered from beech bark depends on the details of the extraction method used. Nature produces a wide range of structures, the extraction pulls out a subset of that. But different methods won’t pull out the exact same subset of structures. So the product is very dependent on the details of the natural source and the processing method.

Then the product is chemically modified (by sulfonation and probably other steps), which also won’t necessarily produce a well defined product, but a mixture of close variants.

The FDA registration is for the specific product from Bene. To reproduce it to the degree that would conform with the characterization held by the FDA probably requires the same variety of beech trees grown the same way, extracted with the same processes under the same conditions and subsequently processed the same way, to produce a mixture of close variants with the same fingerprint. This is very difficult to replicate exactly.

So it’s not simply a case of synthesising a specific molecule, but replicating a specific mixture of semisynthetic polysaccharides. That’s a lot harder.