Yes, FDA Approval is hard to get, and this company has never gotten anything FDA Approved. Excellagen is considered a medical device, not a drug. Medical devices do not require proof of safety or efficacy to be "cleared for use" by FDA. Devices only require the correct paperwork be filed in order to be "cleared for use", and that is all that has happened here. The company seems to have publicly backed off their strategy of touting the MATRIX study data as being "impressive" and "robust" to support the use of Excellagen (for good reason), but I would love to get a visit from one of their 150 sales reps to hear what they actually have to say about it. If I do, I'll record it and post a transcript.
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