Pledpharma: Knocking on FDA’s door2015-11-11 20:57, Edited at: 2015-11-11 21:02
All eyes are now completely focused on the upcoming end of Phase II meeting (PLIANT study) that the company will soon be holding with the FDA. The meeting is expected to clarify the authority’s view of the documentation and provide a recommendation regarding which studies are needed to achieve registration of PledOx in the US. With this in hand, discussions with partners can commence in earnest, and we expect this will considerably increase the temperature of the stock market with regard to the company. The third quarter report offered no major surprises. The costs of the PLIANT study have begun to decline and we expect this trend continues over the coming quarters.
Following the report, we have made only minor changes to our forecast, and these have had no meaningful impact on our valuation. Consequently, our fair value remains unchanged at SEK 58 per share.
Note. This is a translation of the original report released the 23rd of October.