by DrKSSMDPhD | December 18, 2017 11:08 am
Arch Therapeutics ($ARTH) has withdrawn its 501(k) device-approval marketing application with the FDA.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, they would have done so.” He reminded me that Arch has communicated with the FDA on a regular basis throughout the regulatory submission interval, and Norchi has emphasized this with me before in face-to-face conversations during the fall. Throughout, the tone has been friendly and non-adversarial.
Meanwhile, he emphasized the company continues manufacturing AC5 in scaled-up mode. “Look, it’s not like I picked up the phone this morning and called the factory and told them to put manufacture on hold. Not true. It’s full steam ahead.”
He is somewhat uncertain how the next few weeks will play out, but will know more when the FDA responds in writing as to the full set of information it seeks from the company. The company will then resubmit the 510(k). “It sets us back a quarter, two quarters at worst.”
He reassured me that partnering opportunities appear to be “in the works” and that trial planning for the internal use agent is in the advanced stages, and that nothing that has occurred this week will delay that.
“I can’t tell people how to invest, but in many ways it would appear to be a buying opportunity for investors,” he said.
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