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The company does not undertake any obligations to update ant forward looking statement whether as a result of new information, future events or otherwise. The loss of key scientific or management personnel. I would now like the turn the call over to Dr. Moreover, we believe that the positive results achieved in the Thorough QT study that we announced this morning provides further support to the cardiac safety of Callie davis and strengthen our upcoming NDA submission.
Physicians are becoming increasingly concerned as the promise of resistance and collateral damage manifest themselves in private practice, in addition to the hospital setting. And we believe those results offer compelling evidence to support the commercialization of the drug. And potential partners are valuing Cethromycin on its CAP potential as well as the overall community based antibiotics space. Advance Life Sciences has Krypton krypton mankato msus shtml web a great deal towards this endeavor in the past two and a half years. And we remained bullish about the future of Cethromycin and about our company. John will now provide you with an overview and update of our drug development programs.
As Mike noted earlier, we made tremendous progress and development of Cethromycin in, as well as added significant value to our Deandre levy vincent position with the drug.
Ve had recent direct interactions with the FDA following our clinical program and our discussions with them have not changed our view on the adequacy of our trail design. Our NDA is further enhanced by the positive results demonstrated in the Thorough QT study that we announced this morning. The US FDA requires Thorough QT studies for all new chemical entities, because prolongation in the QT interval proactive for changes in heart rate or QTC may signify and increase risk of developing cardiac arrhythmias in patients. A Placebo corrected QTC mean change from baseline using the individual correction method for heart rate or QTCI for the therapeutic and supratherapeutic doses of Cethromycin were negative. In additions to the values for the mean QTCI interval, none of the subject from the Cethromycin cohorts showed increases in the QTCI of greater than K vitamin warfarin nor did any of the Cethromycin subjects display a QTCI that exceeded milliseconds at any time.
No hepatic safety signals, No new hepatic safety signals emerged in the study and were consistent with all prior clinical studies. The company remains confident in its regulatory strategy for Cethromycin in the CAP indication. Advanced Life Sciences requested and established a meeting following the Advisory Panel, which will take place on April,, directly with the FDA to discuss the Transgender girlfriend NDA submission for Cethromycin in CAP. Following that meeting to discuss the outcome of the April. Again a summary of upcoming communications on April.
S meeting with the FDA to complete our NDA submission activities for cethromycin as a treatment for CAP. We intend to finalize negotiations with potential commercialization partners for cethromycin. S activity against high priority bioterror agents for its use as a broad countermeasure. We completed our pre clinical studies and commenced work with CRO on the design of a Phase I II study in melanoma.
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The net loss for the full year was.
We believe that this cash balance puts us in a very strong financial position to execute on our plan of completing the NDA submission for CAP and completing our commercial transaction. And your first question comes from the line of Angela Larson from SIG.
S why we would structure the transaction in a milestone on a royalty based approach. I would not expect, even the finances were not the issue.
The cost going forward this year in terms of our estimated cash burn I was clearly focused on NDA submission and the Abby newton manufacturing ramp up activities as well as some small R amp. Hi, guys thanks for taking the questions.
M just giving you a prospect in terms of what has been seen in the past. What I was referring to there was the advisory panel. Placebo and Emerson knife were the same across both Cethromycin cohorts. THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY. Ul long ideas box display block.
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