The novel drug - A DMOAD approach, page-21

Im with 5cata...off patent for more than two full decades but no copies to date...some have tried, some came sort of close, no one can do it consistently, no one has done it exactly.

One Indian pharm outfit went as close as asking the FDA to look at what they had...there are just too many inconsistencies...the mass spectrometer/chromatography isn't coming back with the same fingerprint type molecule picture every time....


Yeah, this is what we own....




Dont forget, ours is highly consistent and contains some 40 individual molecules within the overarching molecule.
The process to manufacture this (courtesy Bene) has been developed over decades, they have been manufacturing it since 1940.

You get one step wrong out of the hundreds of individual steps, you change the temperature for example, in just one of those steps and the end result is DIFFERENT. It can have wide ranging ramifications....the FDA will not accept anything other than what's on their file. They have told us this specifically in our PRE IND.


Want another story...there is one room in the Bene Factory, it contains a 3 storied silo...this is so designed to get the rate of the sludge from the top so it transposes at the perfect rate so the consistency of material is perfect when it hits the bottom. This machine is hand built...

How can a competitor that just starts up, replicate such precision over a number of steps? It might be possible, but it will take years of refinement.


Batch consistency is randomly audited every year (GMP), Bene have passed this test for years.