Arch Therapeutics ($ARTH) has withdrawn its 501(k) device-approval marketing application with the FDA. I spoke with CEO Terrence Norchi, MD, MBA, by phone this morning for clarification and to ask a few questions.
Norchi explained that he regards Arch’s relationship with the FDA as “good and friendly” and wants to be cautious not to jeopardize that in any way. Last week, the FDA approached Arch with a set of questions. However, the FDA is governed by Congressionally-enacted law as regards MDUFA and the timetable for device approvals, and given the timetable already set into motion, the company had but one day to answer the questions. The FDA wasn’t being vindictive or unreasonable, but was stuck within legal constraints and could not afford the company and additional time to respond. “Answering in one day was impossible,” Norchi said. In order to preserve the good-natured relationship the company has established with the FDA, Norchi and colleagues felt the wisest course of action was to withdraw the application, await full written requests from the FDA for further information (which are as of yet unavailable), and then respond to those in a circumspect way with a resubmission that resets the submission timetable. I pointed out to him to that we recall Esperion ($ESPR) being badly burned by assuming it had heard one thing from the FDA and then getting something materially different in writing. Norchi is unwilling to go into the specific nature of the additional information being sought until he hears in writing from the FDA. Even then, revealing that data may be imprudent because of the immune-from-discovery nature of an FDA submission.
Norchi said that there are three cardinal areas that the FDA’s queries do NOT pertain to. First, the predicate strategy of AC5 being a device, and the class of device it is or will be is NOT in question. The FDA disputes nothing along these lines. Second, the facts and data contained within the large biocompatibility package submission according to the 10993 list is not under dispute and has not incurred a request for more information. Third, the data gleaned from the AC5 external use Irish clinical trial is not in question and will not require further study.
Norchi admits all this was “a bit of a surprise” but adds that “I really got the sense that were the FDA able to give us more time, more than a day, ...