February 3, 2009
Here is the question I hear most often from shareholders: How much do I personally believe in the future of OXBO?
The answer very straight forward: Absolutely. Our company is one of the few very-small biomedical ventures having a multi-pillar strategy in the clinical and the topical sector. As a result, we have strategic alternatives for all the speed bumps we currently have to circumvent. What our team has accomplished in just a year is impressive and it is making me very confident for our future.
So why was I not an employee of the company in the past? As a matter of fact, I have already received a major portion of my compensation in restricted stock. The reason why I have been working based on a consulting agreement since joining the company was that I could not simply or quickly wind down all my other mid-term obligations after the unexpected passing of then CEO Bob Larsen in March 2008. I have always said that once these obligations were over, I would be willing to become an employee of the company. Subsequently the board has asked me to follow-through and we have already agreed on terms and conditions effective February 1, 2009, as you will see in our 8-K filing today.
As I said, I believe absolutely in the future of this company. That’s why I am now an employee.
I also want to use this blog to address the status of our dealings with the FDA and our plans for Oxycyte.
Many people think we are completely dependent on the FDA. I do not think that this is the case. When we received the recent letter from the FDA informing us, that after reviewing our data, they are not yet ready to allow us to resume clinical trials in traumatic brain injury, we were surprised with their conclusion. We were especially surprised since the FDA made very specific comments in the letter about the data which suggest that not all the information in our package had been considered. At the FDA’s request, we had submitted computer-generated data files with written discussion of the risk-benefit profile. The comments we received back appear to reach mathematically unexpected conclusions and do not address the evidence of benefit which strongly suggests a continuing misunderstanding of the data. We feel this is a strong basis from which to seek reconsideration and are moving to bring that about.
However, just focusing on additional TBI trials in the United States as the only avenue to develop Oxycyte could mean missing other opportunities. When we prepared our dose escalation study protocol, we did so with a conservative posture to evaluate efficacy of lower doses already found to be not associated with safety concerns. Rather than lose any more time, we will be filing the same protocol we intend to submit to the FDA in three other countries, two of which are in Europe, as initially planned. We will then be just very opportunistic. Wherever we get the first go-ahead, we will start and then may, or may not add the other test areas to the ongoing trial. Interestingly enough, other drug development companies often use this avenue to expedite clinical trials since companies can submit certified trial data from anywhere in the world.
In addition to our clinical products, we are working on our topical products. There, we have a step-by-step approach, starting with a very simple ointment, then scaling the complexity through oxygen delivery with hydrogen peroxide, and going on to clinical and battlefield products in the wound sector. We think dermatology and even cosmetic indications could follow.
These other product channels should have a shorter time frame for testing and getting to market. Our goal is to generate income from the topical sector as soon as possible to carry the company’s ongoing expenses.
The key to any business entity is financial independence. That is what we intend to accomplish with our strategy. We think that a prudent and conservative business behavior, mitigating risks for the company, is just the right thing to do