Advanced Medical Isotope Corp. (OTCMKTS: ADMD) announced some big news yesterday. According to the announcement, the company has completed a key meeting with the United States Food and Drug Administration. Here's what you need to know about the ADMD release...
ADMD Announces Completion Of FDA Meeting
As mentioned above, Advanced Medical Isotope Corp. recently released some big news. The company announced that it has completed its meeting with the FDA regarding pre-submission and a regulatory pathway surrounding RadioGel(TM).
ADMD said that the FDA was incredibly helpful through the meeting. The FDA also provided 14 pages of comments prior to the meeting with insights and clarifications during the the meeting. In their press release, the company said that the FDA's recommendations are being incorporated into the testing plans. It is expected that the bench-top testing will begin late September.
The company also said that detailed animal study plans will be sent back to the FDA for a final review, as it is important that the FDA agrees with the plans before they are conducted. This will ultimately increase the probability that the data will be accepted as adequate to allow the company to move forward with the first clinical studies surrounding RadioGel in humans. ADMD said that the FDA has also agreed to follow-up communications with their experts on specific topics, helping to further ensure that the testing aligns well on complex topics and expectations of the FDA.
During the meeting, ADMD requested that the FDA provide De Novo reclassification as a Class II device based on the risks associated with the device. If this classification is achieved, the path toward regulatory approval will be faster and less onerous than a Premarket Approval, or PMA. To this, the FDA responded that they would need to see the data from pre-clinical testing before making a decision on this classification. This will give the FDA the ability to balance the therapeutic value against risks associated with the device.
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What We'll Be Watching Moving Forward
Moving forward, the CNA Finance team will continue to keep a close eye on ADMD. In particular we're interested in following the company's ongoing work to bring RadioGel to the market. Nonetheless, we'll continue to follow the story closely and bring the news to you as it breaks!
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