I have to believe we are very close to a positive conclusion, based on comments from yesterday's Q. I also believe financing for the ramp up is in place and will not be a problem. I know the last few years have been very dismal here but I think we are very close to amazing things. Given the low O/S, high margins in a $22.5 B market and the new competitive bidding process for medicare, we could see unbelievable returns here. If all goes well, I truly think a share price of $50.00 over the next two years is not unreasonable. It sounds crazy, but I really think it could happen.
Comments taken from yesterday's Q:
We have also continued to ready the company, subject only to receipt of an expected FDA 510(k) approval, to introduce a proprietary diagnostic product, the Shasta Genstrip, for at-home testing of blood glucose.
In anticipation of the introduction of Genstrip, which is in the final stages of FDA approval, and currently completing that approval process
In early November 2012 the company received an informal communication from FDA staff asking for clarification of two issues remaining from the September 2012 face to face meeting. The company responded to these requests. Within the body of the communication received from FDA staff the company was informed that we [FDA] was close to reaching resolution on this issue
The company maintains a practice where comments and questions are responded to as quickly as practical. Since Genstrip is a unique offering, employing a razor blade only model (diagnostic test strip) into a razor (diagnostic meter)-razor blade (diagnostic test strip) market, the Genstrip 510(k) application has presented some unusual challenges for the FDA and an educational challenge/opportunity for the company. Since the company plans additional similar products in the future for other diagnostic platforms, the Genstrip experience, however slow and unresponsive, has provided lessons and experience.
