Biotech General Discussion

FBIO founded ATXI to develop an intravenous version of Tramadol, a patented intravenous formulation of the commonly prescribed, approved generic pain therapeutic, called Ultram among other names. In our view, this PDUFA is an especially complex catalyst, only for experienced biopharma investors with significant time to dig into the facts:

First, you have an opioid drug, which have not been well-received by the FDA in recent years;

Second, ATXI actually is supposed to be acquired by Invagen (owns 33% of ATXI already, and Invagen was acquired by Cipla) if the FDA approves IV Tramadol by April 30, 2021 and the label is not limited to specific surgeries (and FBIO shareholders will share in the proceeds of this acquisition);

Third, If IV, Tramadol is approved by April 30, 2021 and the label is not limited to specific surgeries, litigation between ATXI, FBIO and Invagen appears a real possibility because Invagen has threatened that it will not go forward with its purchase of ATXI due to commercialization challenges caused by Covid; and

Fourth, you've got the challenges of figuring out whether the market will positively respond to an approval here not only given the uncertainty with point 3, but is the data strong enough that IV, Tramadol will be successful enough to trigger payments to ATXI shareholders under the Invagen acquisition agreement.

Of course, there are positive elements of this PDUFA as well. But the above points give you a sense of our view of this PDUFA and these companies as they stand currently, as investors.

#Tramadol #FBIO #ATXI #Pain #opioid