Just some tidbits: Hoping the 510(k) news hits anyday.
The Company expects to incur substantial expenses for the foreseeable future relating to the research, development, clinical trials, and commercialization of its potential products. As of November 14, 2017, we believe that our current cash on hand will meet our anticipated cash requirements into the fourth quarter of Fiscal 2018.
We are focused on scale-up of selected manufacturing methods and formulation optimization. In parallel, we are continuing to conduct further in vivo and in vitro tests
Our current and planned near-term activities are focused on manufacturing scale-up, formulation optimization, and other preclinical activities, and conducting further clinical trial testing of AC5. In its first clinical study for safety and performance, AC5 was demonstrated to be safe and to reduced TTH in wounds versus controls. Our clinical study also demonstrated that in a subgroup of 10 patients who were taking a prescribed antiplatelet medication, commonly known as a blood thinner, such as aspirin, AC5 had similar effects.
We have initiated the transition to traditional contract manufacturing and related organizations. We have commenced relationships and work with manufacturers operating with the current good manufacturing practices (“ cGMP ”) required by applicable regulatory agencies in order to scale up and produce formulation material to be used for final preclinical testing and clinical trials.
...in the EU, confirmed that AC5 fulfills the definition of a medical device within the EU and will be classified as such in consideration for CE mark designation. The FDA and other regulatory authorities or related bodies separately determine the classification of AC5. The FDA also determined it to be a medical device. Generally, a product is a medical device if it requires neither metabolic nor chemical activity to achieve the desired effect. Furthermore, a medical device can achieve its desired effects without requiring a body (animal/human), whereas a drug or a biologic requires a body in order to operate. The AC5 mechanism of assembly into a barrier can occur outside of a body and is accordingly consistent with the medical device definition.
Medical devices in the EU and the U.S. are classified along a spectrum. Class III status, which is the higher-level classification for devices compared to Classes II and I, involves additional procedures and regulatory scrutiny of the product candidate to obtain approvals. AC5 could be regulated as either a Class III or a Class II medical device in these jurisdictions, depending upon the application, subject to the process for obtaining a CE mark in the EU and the premarketing authorization process in the U.S. It has been determined that our AC5™ Topical Gel used for external wounds will be a Class II medical device.
The Company plans to include data from this trial, as well as data available from the U.S. in a CE mark application that we currently intend to submit in 2018 and approval of which is required in order to market and commercialize AC5 as a medical device in Europe. We also expect to use this data in support of additional U.S. regulatory filings.
On July 25, 2017, we announced that we had made a 510(k) submission to FDA for our AC5™ Topical Gel. If our 510(k) application is cleared by the FDA, it is expected that the AC5™ Topical Gel will be used for external wounds.
We currently anticipate filing our first CE mark application after receiving allowance of a 510(K) regulatory submission in the U.S. We have identified several potential countries through which we may pursue a CE mark for AC5.
