TSXV:TRL.H - Post by User
Post by
LTOWNERon Jan 12, 2013 10:24am
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Post# 20829582
Completion of all Data Collection
Completion of all Data Collection Yep is likely referring to the closing of nasal safety data, on or before January 18, 2013. With this final information: 1) prospective partners will have all the data in hand to make a final decision regarding Compleo and 2) Trimel will have all the data required to submit the NDA for Compleo.
The beauty of working with the FDA in setting up drug Trials is the assurance that all bases that may concern the FDA will be covered and therefore a successful trial means the likelihood of FDA approval is very high. The FDA asked Trimel to include a rhinitis study and a 360 day nasal safety study with the Phase III Trial. Primary endpoints for the drug have been met and "Safety data observed to this point are consistent with other testosterone therapies and no drug-related serious adverse events have been observed or reported. "
In addition to the Trial data, prospective partners have the information from two highly positive marketing surveys, one from physicians who prescribe T-replacement drugs and one from patients (users) who have taken T-replacement drugs.
Full details of clinical results can likely not be made public until they have been filed with USPTO as part of patent protection.
As noted in a previous post, enrollment of the nasal safety cohort was completed January 18, 2012, with these patients to be followed for up to 360 days. They are looking for possible side effects of delivery on nasal mucosa and so far there have been none.