Montreal-based Theratechnologies Inc. is planning a FDA submission shortly, after a three-month delay, for its novel therapy for multi-drug resistant HIV, ibalizumab. Analysts are confident of its quick success at the agency, given the novel product's efficacy and the unmet patient need, which should propel the company to a different league, sales-wise. HIV may have morphed into a long-term illness with the arrival of highly active antiretroviral therapy, but more and more patients are now running through the current treatment options, increasing the demand for novel treatment strategies.
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