I feel we are past step one, but for humans I would be okay holding a couple years. At least a core position. After taking some profit with IsoPet revenue next year. I should of pulled my principle at .04 and rode with free shares, but I am still feeling good about RDGL over the next 3-5 years. I'll continue loading where it makes sense. Though I think we'll see a win in 2019 for sure. Also, Right to Try gives them another way to speed up the process possibly.
RICHLAND, WA / ACCESSWIRE / September 7, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company, submitted a 233-page request to the Food and Drug Administration (FDA) for a pre-submission meeting to review the test plans for the remaining pre-clinical testing and to request a De Novo path for its pre-market application. A De Novo path is faster and less onerous than standard Premarket Approval pathway.
The FDA was very helpful, providing 14 pages of comments prior to the meeting with further insights and clarifications during the meeting from the 12 participants. Their observations and recommendations are being incorporated in the Company's test plans. The bench top (in vitro) testing will begin late September. The detailed animal study plans will be sent back to the FDA for a final review. It is important that the FDA agrees with the plans before they are conducted to increase the probability that the data will be accepted as adequate to allow the first clinical studies of Y-90 RadioGel™ in humans. The FDA also agreed to follow-up communications with their experts on specific topics. This is beneficial to ensure that we are totally aligned on the most complex subjects.
In previous written feedback to ADMD, the FDA recommended Premarket Approval (PMA) as a Class III device. In this meeting, we requested consideration for a De Novo reclassification as a Class II device based on the risks associated with the device. A De Novo path is faster and less onerous than a PMA. The FDA responded that they would need to first see the data from the pre-clinical testing so they could balance the therapeutic value versus the risks. We interpret this as encouraging since they did not refer to a PMA path and we expect the test data will demonstrate that RadioGel™ is a low to moderate risk device with clear therapeutic benefits.
