Novice investors are excused, any professionals know that PATH needs a manufacturer, whether they enter into a long term agreement with one or buy one. An agreement means they pay out of the nose to produce product, buying one means price control and security.
Buying one is why the current price is $2.60.
Got the picture? GSk wants to see numbers before they lay down the big bucks
If you read the various releases you'll see they already had a manufacturer lined up and were installing and validating the production lines back in 1Q '13. For a 4Q launch they need to be producing product in the 3Q '13. I'm sure they are already warehousing materials and product somewhere already. It is probably not in the final packaging yet but is probably just one or two steps below that step in the manufacturing process. The drug itself is purchased and not made so this is primarily a process of making the patches. Once the patches are made they'll probably be packed and stored in bulk until they have final approvals on the inserts and other packaging components. Then once everything is in place, it's a simple matter of doing a packaging run where everything is put together into the final kit. A good company can churn out thousands of units in a few days once they get the go ahead.
They are using the same manufacturer that produced the clinical supplies. If you know ANYTHING about the drug and chemical industry you would know that MANY, MANY companies out-source the production of their products. It's a very common practice and often more cost effective than maintaining your own facilities.
No doubt PATH is in a good place with the 4th q launch and I am the first to agree that they are only a step away from being compliant with current good manufacturing practices. That said drug must meet patch and if you read all the sec required reporting, path is PATH is the manufacturer.
Outsourcing works no doubt but, not in this situation especially with additional indications for the smart-relief patch.....Keep watching