AXP @ $1.34, page-11

The main point that seems to have been slightly clouded here by the announcement today is that the first release of the product is approved and can now be sold in the USA. This was *the* key risk for the company.

They also mentioned today they will be filing for another 510k which is to clear a minor modification to the product. I believe this addresses some minor failures they found during clinical trials (note that the product was still approved with out these modifications). However, I'm sure they want to have as minimal issues as possible, so they won't do their major release product release until this is approved. This will give them plenty of opportunity to sell their approved product to key customers as a soft launch to better understand the US market, imo.

The traditional 510k process is a 90 calendar day clock on the FDA, so each time they ask questions to the manufacturer, the clock stops. They will probably get 1 round of questions for such a simple set of mods. So assuming a considered response from AXP of 1 month, then you are looking at 4 month to approval. In the call today, they said they will put in submission within 2 weeks. Obviously they have been sweating on this first approval, so they have a near fully prepared submission ready to go.

No talk of CR during call. Just based on recent cash flow, it seemed a close call, but maybe with the December approval, they might not need to as there will be pent up demand. If it does happen, it will probably be a small raise and done with their current significant holders and high net worths.

They seem quite responsible fiscally, as they said they will bring on sales staff gradually over the year and will go with commission only sales initially in some areas to keep costs down. I like this approach. The management are very focused each time I hear them speak and are very experienced in all the key activities they need to currently complete (form my research).