I agree. I think the company has a level confidenc
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Posted On: 11/12/2018 5:08:36 PM
I agree. I think the company has a level confidence in receiving BTD. As has been reported data shows clear efficacy in treating severe Oral Mucositis. OM is a unmet medical need. If BTD is granted all things fall into place imo.
Company has also spent one $million readying B oral rinse for future trial.
From Sept.20 corporate update-
Brilacidin for Oral Mucositis. In coming weeks, the Company plans to submit a request for an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss appropriate next steps in the development of Brilacidin for the treatment of Oral Mucositis (OM), which has already been granted Fast Track designation. A Breakthrough Therapy Designation application is currently under review with the FDA. OM represents a large unmet medical need and is estimated to be a $1 billion market opportunity. The Company plans to focus its efforts on the advancement of Brilacidin oral rinse for the prevention and control of severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving the most aggressive regimen of chemoradiation, with chemotherapy administered in high concentration (80-100 mg/m2), approximately every 21 days (q3wk), as clear efficacy and good toleration were seen in treating this patient population.
Company has also spent one $million readying B oral rinse for future trial.
From Sept.20 corporate update-
Brilacidin for Oral Mucositis. In coming weeks, the Company plans to submit a request for an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss appropriate next steps in the development of Brilacidin for the treatment of Oral Mucositis (OM), which has already been granted Fast Track designation. A Breakthrough Therapy Designation application is currently under review with the FDA. OM represents a large unmet medical need and is estimated to be a $1 billion market opportunity. The Company plans to focus its efforts on the advancement of Brilacidin oral rinse for the prevention and control of severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving the most aggressive regimen of chemoradiation, with chemotherapy administered in high concentration (80-100 mg/m2), approximately every 21 days (q3wk), as clear efficacy and good toleration were seen in treating this patient population.
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