MADE IN GERMANY, page-9

SunnyCoast, I agree with you. Scott would definitely have raised this if it were this an issue.

Pharmd - all very good questions, we actually have also covered this before a while ago but no doubt some of the old discussions are quite far back, hard to dig up and there are many new guys reading all of this for the first time.

Yes it will be hard to directly glean this info from Bene BUT here are the facts:

1) Bene have been manufacturing at some sort of scale for 7 decades, as we know they are a professional world class out fit. The FDA will not grant a GMP stamp of approval to any old outfit that fumbles when orders get large...or even larger as our case will show eventually... it is all about capacity and growth forecasts, this will be well and truly covered by the authorities (FDA and EMA) as well as Bene and PAR. They already have some idea of the future scales involved.

2) Elmiron and other products are still sold in volumes. Sure not quite the volumes we hope to get....but still relevant.

3) There is scope for them to open more production plants as sales increase and forecasts get adjusted. They already are a medium sized business (ie its not just 4 staff and a couple of uncles that help out on weekends)...it's a professional and fairly large scale op now.

4) Beechwood trees are a plenty...forests of them, measured in the longitude and latitude measurements ¹...you wouldn't need much to make the small quantity that patients require...it's already used commonly in Europe for furniture etc. Note: It does take a LONG time for these beauties to grow (10 years for the first 2 feet !)...but there are plenty...

5) Our trajectory albeit quite exponential at times, will be a smooth one at least initially. A gentle increase with the TGA...then a ramp up of more Aussie sales, then OA..possibly one jurisdiction first (eg US) and then a few months later perhaps Europe...then it will go slowly nuts and increase a lot. (All my views here). My point is that they will have time to ramp.. Just like my team of forecasters and analysts (err all just me, sorry)..will be able to re-plan and re-forecast when sales come through, they will actually have people that do that for them as well.

6) Do not be fooled into thinking they ran out already for SAS program. This wasn't the case. There were delays due to auditing and batch number tracking and there is currently no streamlined mass scale distribution in place...I'm not saying there won't be hiccups and some delays...I am saying that supply overall will be fine from what I know. Of course don't rely on me. If I get more (non sensitive) info then you know I will let you know.

Std disclaimers - DYOR.

Reference:
https://medium.com/@Woodbeei/european-beechwood-everything-you-need-to-know-about-it-33eae766042c