scenario

Decisions…decisions…what to do. Imagine this scenario:

We’ve just spent months and hundreds of thousands of dollars on documenting a water tight 510k clearance submission for Oraline iv. It’s complete and ready for filing. Once it’s in we know we have a maximum 90 days wait (probably much less) for FDA approval and a huge pipeline of potential customers and contracts. We already have on board a US operations manager to drive these new deals.

But our potential Mexican deal – which is substantial - is moving ahead, albeit slowly. The Mexican Government has finally confirmed that saliva-based testing is the preferred technology and is now free to complete negotiations with Express Diagnostics on the supply of OraLine iv. But there’s a catch. Unless we set an export precedent prior to FDA filing, our certificate of exportability becomes null and void.

So what to do? We don’t want to file for 510k clearance and thereby jeopardise the Mexican deal. But we don’t want to wait for Mexico for too long because that is delaying FDA clearance and the forging of significant new US (and other country) deals.

So let’s get together with the FDA and see what we can work out. Perhaps they will waive the need for an export precedent – that is, allow us to export to Mexico after we have filed. It’s worth a go – but being the bureaucrats that they are, they’ll probably stuff us around for awhile.

Big things are happening and patience will be rewarded on this one