Share Search
Visit the Share Search
ImmuPharma confirms continued FDA delays for Lupuzor
11th Sep 2020 12:17
(Sharecast News) - Specialist drug discovery and development company ImmuPharma on its special protocol assessment (SPA) submission to the US Food and Drug Administration (FDA) for the phase 3 trial of 'Lupuzor' in lupus patients.
The AIM-traded firm said that, in its discussions with its Lupuzor licensing partner Avion Pharmaceuticals, Avion confirmed that while the review period by the FDA for an SPA request was normally up to 45 days, which had now passed, Avion had still not received a response from the FDA.
"As such, the file is still in the review queue, due to the current workload at the FDA," the board explained in its statement.
"ImmuPharma will provide an update to the market as soon as Avion has received a response from the FDA and notified ImmuPharma."
At 1205 BST, shares in ImmuPharma were down 5.01% at 12.8p.
The AIM-traded firm said that, in its discussions with its Lupuzor licensing partner Avion Pharmaceuticals, Avion confirmed that while the review period by the FDA for an SPA request was normally up to 45 days, which had now passed, Avion had still not received a response from the FDA.
"As such, the file is still in the review queue, due to the current workload at the FDA," the board explained in its statement.
"ImmuPharma will provide an update to the market as soon as Avion has received a response from the FDA and notified ImmuPharma."
At 1205 BST, shares in ImmuPharma were down 5.01% at 12.8p.