RE:RE:RE:RE:RE:RE:Letter “new accretive product acquisitions or in-licensing of commercial assets”
“Questions raised by the FDA were already being addressed by our team as part of our sub-analysis of the data accumulated so far, and we are confident that we will be able to address all of their questions.”
“The further development of TH1902 will be stage-gated and depend on the analysis of the data generated, and decisions will be carefully taken in the context of our goal to become EBITDA positive in 2023 and beyond.”
“Both the NASH and HIV markets in the United States have considerable opportunity, and we believe that we are well positioned to capture market share in the future.”
So apart from the guidance for 2023, 13 to 16 pre cent sale growth!!! they are talking about in-licensing of commercial products!
My take about “stage gate” specifically in context of costs isn’t that they won’t proceed with trial but when they do it will be a feasible approach. This is the question many including one of the analysts was asking, whether it’s even worth to restart the trial considering the costs and benefits.
The message seems to be we have a commercial operation with promising potentials, the protocol amendment and trial restart will be based on thorough analysis from the experts and the cost associated with it will be considered for each stage before proceeding with it. NASH has been mentioned as opportunity which they don’t want to let go.
Less details about pausing and restarting the trial and no time frames which I certainly hope will be discussed and explained in details before the trial resumes or better sooner!
But the letter is a decent attempt to reassure investors that the company will be in good shape financially regardless of the costs of the R&D activities in the near and long term based on a well thought scientific and cost analysis, both oncology and NASH are still very much alive with potentials...