Theratechnologies (TSX:TH) announced that it has received feedback from the FDA regarding the timeline to review tesamorelin’s New Drug Application for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA has indicated that the review is progressing well. The Company now expects to have an official response in the fourth quarter of 2010. Theratechnologies and the Agency continue the positive and constructive dialogue regarding the regulatory process for tesamorelin.
We have been told that the delay is due to labeling issue, we believe the issue is minor. The fact that labeling discussions are ongoing is a clear indication that we are moving towards approval. This delay for labeling issue reminds us Nuvo Research (TSX:NRI) story, they also had a delay for labeling issue and investors got another opportunity to buy the weakness just before another huge run-up to the final FDA decision. This is exactly what should happen here again for Theratechnologies.
We believe Its a buying opportunity here as we feel, as do BMO and other analysts that approval is kinda in the bag. Why do you discuss labeling if you are not going to need a label? Usually when you talk about labeling, you have reach the latest point of the FDA approval process.
There has been zero insider transactions in the last month. Almost all insider activity in the last year has been buying. BMO’s latest note, maintained a buy rating, maintained price target, and recommended buying on current weakness.
You may read our latest article about Theratechnologies:
www.thecleverbull.com/articles/view/article/2/Tesamorelin-PDUFA-date-July-27th
Full Disclosure:
-No positions on TH
-The Clever bull has NOT been compensated in any way by theratechnologies to promote or write this article.
The Clever Bull team.
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