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[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.]
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 2017.
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 …
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