The article "Venaxis still faces "enormous" challenges," in essence, is correct, though it posed no details to back up such a statement. Any company seeking FDA approval and distribution has enormous challenges, however it is the company's ability to face these challenges that really should be addressed.
Venaxis (APPY), formerly Aspen Bio, has made mistakes in the past. I believe the "rebranding" to Venaxis is more than just a name change- not only does the name better fit what the company does, it also distances itself from the past. Venaxis, as the company's new front, has learned from past mistakes, and not likely to make any moves that would damage its new image.
Venaxis has more than just a new name. For the first time, it has a product, APPY1. The CE mark itself is not huge, but is no small achievement, either. Having a product shows Venaxis' ability to manufacture what started as an idea, and to exacting specifications. European distribution will be great for its financial bottom line, but true value comes into play with marketing and distribution.
The experience gained from an overseas launch, prior to an FDA approval in the US, allows Venaxis a test run. They learn the distribution process, receive critical feedback, and all without affecting their primary market, the US. Experience in Europe will play a pivotal role in their ability to ramp up and distribute in the US immediately after they gain FDA approval.
The fact that the product is marketed in multiple countries will benefit the company, as well. As stated in the last webcast, each country in Europe is a little different when it comes to its medical system. These variations give Venaxis the opportunity to work with several different approaches to medicine, all contributing to the company's overall development and understanding of the worldwide marketplace.
APPY has hit the $20 mark 5 times in 5 years (excluding 2012) and has gone over $70 without a product in place. Venaxis made a mistake pushing for FDA approval very prematurely. I believe the experience Venaxis has gained over the last few years will greatly affect the outcome in the next 6-12 months.
This stock has great potential. There are big changes pending on the outcome of the clinical trials and submission to the FDA. Venaxis could either to jump to $20+ with a positive outcome or it could go to $1 if it ends with poor results. The big question is: Do you believe they have a product worthy of FDA approval? Is it strong enough? For me, yes.