Posted On: 03/18/2015 10:33:28 AM
Post# of 223
BioPharmX Corporation Completes Pre-IND Meeting With U.S. FDA To Review Its Topical Acne Solution
MENLO PARK, Calif., March 18, 2015 /PRNewswire/ -- BioPharmX Corporation (OTCQB: BPMX), a specialty pharmaceutical company focused on the development of novel drug delivery products to address unmet needs in large, well-defined and underserved markets, today announced that its planned pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) was held on March 11, 2015, as scheduled. The pre-IND meeting focused on the company's topical antibiotic acne compound currently under development and the company's proposed strategy for advancing its acne program and plans for conducting safety and toxicology studies, along with human clinical trials.
The company received FDA comments and exchanged a list of questions prior to the meeting. Following the conclusion of the meeting, the company believes that it has sufficient guidance from the FDA for advancing toward an IND application for phase II clinical trials.
"Based on our discussions with the FDA, we are encouraged to continue to advance the development of our topical antibiotic acne compound," said Jim Pekarsky, chief executive officer and co-founder of BioPharmX.
MENLO PARK, Calif., March 18, 2015 /PRNewswire/ -- BioPharmX Corporation (OTCQB: BPMX), a specialty pharmaceutical company focused on the development of novel drug delivery products to address unmet needs in large, well-defined and underserved markets, today announced that its planned pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) was held on March 11, 2015, as scheduled. The pre-IND meeting focused on the company's topical antibiotic acne compound currently under development and the company's proposed strategy for advancing its acne program and plans for conducting safety and toxicology studies, along with human clinical trials.
The company received FDA comments and exchanged a list of questions prior to the meeting. Following the conclusion of the meeting, the company believes that it has sufficient guidance from the FDA for advancing toward an IND application for phase II clinical trials.
"Based on our discussions with the FDA, we are encouraged to continue to advance the development of our topical antibiotic acne compound," said Jim Pekarsky, chief executive officer and co-founder of BioPharmX.
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