Theratechnologies Confirms Bioequivalence of New Tesamorelin Formulation - Seite 2

Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", “would”, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of the filing of an sBLA with the FDA, the development of a multidose pen injector, the attraction of new patients and the future development of tesamorelin.

Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the manufacture of GMP batches and the conduct of stability testing will not be delayed and will yield positive results, the use of a device for the administration of tesamorelin will not modify the bioequivalence profile of tesamorelin, a device allowing a small injection of tesamorelin will be available to the company and the company will be able to enter into an agreement for the development and supply of such device on satisfactory commercial terms, the FDA will approve the sBLA and the marketplace will accept the F8 formulation of tesamorelin.

Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, the risk that delays occur in the conduct of stability testing and the manufacture of GMP batches of tesamorelin using the F8 formulation, problems occur during the manufacture of GMP batches or that results from stability testing are not positive, delays in the filing of the sBLA occur, the FDA does not approve the sBLA, the development of a multidose pen injector may not materialize due to the development to be conducted, or problems in finding a suitable supplier for a device or that the marketplace does not accept the F8 formulation leading to low sales of this new formulation of tesamorelin.