by DrKSSMDPhD | December 2, 2017 2:01 pm
[Ed. Note: Dr. KSS writes about biotech and medicine for the Irregulars. He adheres to our trading restrictions, choses his own topics, and his words and opinions are his own. His past articles and most recent comments can be found at his Stock Gumshoe page[1].]
Dr. Norchi called me at home this morning to provide an update regarding the AC5 device submission. He was warm, collegial, upbeat. He said the company has been inundated with calls regarding the approval/authorization status.
He explained to me that what has led to confusion is a posting on the FDA website mentioning Arch Therapeutics and alluding to a class I device.This, according to Dr. Norchi, has nothing whatsoever to do with the company’s regulatory submission. It is merely a company registration mention, a kind of placeholder that indicates that Arch is known to the FDA’s device group as a biotechnology company pursuing medical device marketing authorization. In the manner in which it appears, it is needlessly misleading and confusing. And there is nothing Arch can do about this. “People have read entirely too much into seeing that,” he said. The mention relates to the company not what the company is pursuing.
And in fact nothing has changed. Arch is pursuing class II device marketing authorization. The regulatory filing was submitted on 17 July 2017, and the FDA has six months to reply, meaning that nothing may be heard before 17 January 2018.
Terry said that the company has gotten no formal feedback from the FDA yet, and neither would they expect to have. He also explained that given the nature of these regulatory filings, the FDA is prohibited, under premises of confidentiality, from disclosing anything about what it is thinking until it has concluded its deliberations and notified the company. This is thus even more reason that the placeholder mention has no pertinence to what is going on. Suppose the FDA were contemplating making AC5 a class I device; it could not disclose that at this stage in the proceedings. The likelihood of the FDA making the agent class I is essentially nil, in my view, and Dr. Norchi agrees.
Terry explained that the company has said nothing about what is happening because above all else there is nothing to report. “Look, we are not going to offer a play by play about this…that wouldn’t be appropriate, wouldn’t be professional, and we’ve got so many other things more important we’re attending to.” He said that things are breakneck busy at Arch.
In a face-to-face conversation I had with Terry in the fall, at The Micro-Cap Conference in New York City, he mentioned that he had fielded a couple of calls from FDA reviewers going over their documents just seeking clarity…explanations for what figure legends meant or where some scientific detail might be found in the document. He said those conversations had been friendly, and collegial, and that one FDA reviewer had even commented something to the effect that the submission is “great stuff, very cool.”
The company will make no further announcement about the status of AC5 until it officially hears back from the FDA. I said to him I’d be utterly stunned if the product were not approved given what I have observed of these goings-on over the years and given the “comparables” (I used that term loosely…there are no true comparables to AC5 the agency has approved). He agreed. “We just don’t foresee that [a rejection] happening.”
Terry said, “2018’s going to be a huge year for Arch.”
Source URL: https://www.stockgumshoe.com/2017/12/special-comment-update-from-arth-ceo-terrence-norchi-md-mba/
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