Got an email-reply form the company today:
"Thank you for your recent inquiry to Biomoda. As we announced in late June, we have completed enrollment and patient sample collection for our pilot clinical trial for early detection of lung cancer using our patented assay. This is a significant milestone. The study team currently is analyzing data in accordance with the study protocol. The integrity and thoroughness of this clinical study is of paramount importance to those of us at Biomoda. As such, we continue to work diligently to complete the study and issue its results.
The results of the pilot study will be published in a peer review journal determined by Dr. Bauer, the Principal Investigator and primary author of the paper detailing the clinical study. Biomoda anticipates issuing a media release with a summary of the results prior to publication of the paper. We expect this media release to be the first public announcement explaining results of the pilot clinical trial. We will make sure you are on our email list for distribution of the media release.
Dr. Bauer and the clinical team will determine the publication in which the full paper will be published. We expect they will balance the necessity of thorough peer review and prestige of a publication with the desire to publish results quickly. In all cases, the clinical team will expertly document and analyze data for the most insightful understanding and explanation of the assay. We view the work being completed now as an essential step towards commercialization. I cannot provide you with a timeline for publication. I will reiterate that we have completed a major milestone with the completion of enrollment and sample collection from patients. We are diligently completing data analysis. We will issue results when most appropriate to provide a strong basis for the pivotal trial.
We anticipate beginning the multi-site pivotal trial later this year, and expect this larger trial to extend into 2012 at which time we will prepare and submit the results to the FDA for commercial approval.
I hope this answers your questions. Thank you for your interest and support.
Sincerely,
Maria Zannes"
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