re: Ann: FDA lifts hold on smoking cessation ... today we ran up. But... looking ot the release, the news was actually in part negative. Invion had to restart its trial... At any rate they should now be enrolling at 3 times the speed, but probably at greater cost, because they have to manange 3 sites.
As far as i can make out 'clinical holds' are usually very serious, not just to 'align' trials but because of safety concerns or serious design concerns (designed so the trial would not have a chance of meeting stated objective).
The silver lining is that FDA have now had a good look and hopefully will not step in again. Probably a fair bit of work to get it started so soon again, hats off to the experienced team. The other good news is this happened in enrollment and not further down the track.
If anything this release should have pushed the price lower, but it didn't.
Release below:
FDA clears path for “Smoking Cessation” clinical trial of INV102 (nadolol)
Invion Limited (ASX: IVX) is pleased to announce that the US Food and Drug Administration (FDA) has removed the clinical hold on Invion’s phase II ‘smoking cessation’ clinical trial of INV102 (nadolol) in patients with pre-existing chronic obstructive pulmonary disease (COPD).
On 20 December 2013, Invion announced that the FDA had requested changes to the ‘smoking cessation’ clinical trial protocol that resulted in a halt to enrolment (clinical hold). Subsequent to Invion’s prompt and full response to FDA requests, the Division of Anesthesia, Analgesia and Addiction Products (DAAAP) accepted Invion’s amendments and has lifted the clinical hold.
While the changes were sufficient to require a re-launch of this study, Invion has expanded the number of sites to minimise the impact on timing and reporting. New sites have been selected for their expertise in smoking cessation, COPD, and analysis capabilities of biochemical markers of inflammation and healing.
Invion Chief Medical Officer, Dr Mitchell Glass said, “The FDA took the unusual step of changing our reviewing division to DAAAP after study initiation, which then placed us on clinical hold. Questions raised by the DAAAP were resolved by aligning titration criteria and dosing with our asthma study. These changes will enable sites to recruit and treat our targeted COPD patient population which is in dire need of successfully quitting smoking.”
IVX Price at posting:
9.3¢ Sentiment: LT Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)