Not trying to get nasty Rain. No need for that...
Biomoda CEO Feeling Bullish About Pending Publication of Pilot Study
Biomoda, Inc. (OTCBB: BMOD) has been on many investors radar as a result of the Company’s innovative diagnostic test in lung-cancer which is performed in clinical reference laboratories using body-fluids. We, along with others, are anticipating positive results from the study, in large part based upon historical events. Below is a recent interview with John Cousins, President and CEO of Biomoda, in which he talks about what to expect in the short and long term.
BiomedReports: It has been a while since we first spoke to you. From a science and technology perspective, are there any developments to report?
Cousins: We have made significant progress since we last spoke. Perhaps the most important news for investors and cancer research overall is that we are completing our pilot study of Biomoda’s diagnostic assay for the early detection of lung cancer. Our pilot study, which is similar to the Phase II clinical studies required for new drugs, is the basis for moving forward with a pivotal study — the third and final phase of clinical study that leads to Food and Drug Administration (FDA) approval and commercialization. We are seeking FDA approval of our CyPath® assay as a Class III medical device. The requirements are quite rigorous. The results of our pilot study have not been announced, but we have stated our belief that the results will be statistically significant enough to move into a pivotal study.
And said it many times I might add
We are beginning work on the pivotal clinical study, including responding to questions from the FDA about the pilot study protocol and design, hiring a Clinical Research Organization (CRO) and establishing key collaborations that we will be announcing soon. We will continue research and development to optimize our assay, incorporating improvements such as automation that will lead to larger scale use at lower cost.
The pilot study analyzes samples from about 170 individuals including military veterans at high risk for cancer and individuals who have been diagnosed with cancer but had not yet begun treatment. I know you and others are very interested in knowing the ‘top-line’ results and summary data, and of course we will share those results when they are ready for release. Right now most important for us at Biomoda, and for our experts working on all phases of the clinical study, is the assurance that we have thoroughly analyzed the data and developed the most accurate assay possible. We want to provide an accurate picture of our assay and its performance. A rush to announce results might lead to increased funding opportunities in the immediate future and a short-term pop in the stock, but it can also lead to problems later on, when end points for the pivotal study are not met because the study data from the pilot study wasn’t sufficiently analyzed or the assay was not fully optimized based on lessons learned from
the pivotal study. We will not make those mistakes.
Real airtight operation to be sure
It’s worth mentioning that the Board of Directors elected Maria Zannes as Chairman of the Board. Maria has been the executive overseeing our pilot clinical trial
Why does this person still have a job?
and will continue to provide oversight throughout the pivotal trial. She’s working closely with Connie Dorian, our Vice President of Operations, in development of the assay and conduct of the clinical trials. They are a great team. Connie is an excellent clinical researcher, very detail oriented, and Maria provides a steady, long-term, focused and strategic vision as we move forward.
BiomedReports: Are Phase 2 results still coming this quarter?
Cousins: Biomoda chose one of the toughest cancers when we decided to develop our assay for the detection of lung cancer. We believe the assay platform will be applicable for many cancers. We are nearing completion of the pilot clinical study data analysis and preparing for publication of the results.
Are you honestly going to tell me that this quote in any way suggests the possibility of a flawed test?
We expect results of the pilot clinical study will be sufficient to launch the pivotal trial. We are designing the pivotal study on the foundation of the pilot study and adherence to the FDA’s rigorous requirements. We have a number of steps to complete before the pivotal can begin, including submission of a Pre-IDE to the FDA, the Agency’s response and, if necessary our follow-up to FDA comments. Our pivotal study will be a multi-state, multi-site study. It’s no surprise to anyone who follows our company that we are looking at Ohio and Nebraska as potential sites, and we intend to investigate sites and funding in Texas. I think researchers in those states are awaiting results of our pilot study.
BiomedReports: How is the development of Phase 3 registration coming along? When do you expect to enroll patients? Any developments on money to fund the trial via Nebraska or Ohio?
Cousins: New Mexico provided an excellent model for funding. Biomoda is headquartered in a progressive state for research. We have two national laboratories that conduct impressive research, and, in fact, Biomoda’s technology began at Los Alamos National Laboratory. Our legislature has been very supportive of our veterans who participated in the pilot study. There are other states, including Ohio and Nebraska that have shown an interest in the potential of our technology and are waiting for results of the pilot study.
Hence my point about state funding....guess that money will be waiting a while longer.
FWIW, I follow and respect your DD and board Rain. More importantly I've made money from your picks, lol. I've done my DD here as well. Clearly we've reached different conclusions, but the above words are straight from the horse's choppers.
