What&#x27;s notable about the meat of the complaint sent to the FDA is that it&#x27;s less &quot;this technology actually doesn&#x27;t work&quot; and more &quot;this company has no culture of experimental integrity&quot;.<p>From the article:<p>&quot;hadn’t fully assembled the proprietary machines used for the herpes study when the experiments began&quot; ... &quot;company underreported the rate at which the machines broke down during the study&quot; ... &quot;employee also alleged that some crucial parts of the devices ... were modified to improve their accuracy&quot;<p>FDA is generally skeptical of validation data not generated from &quot;production equivalent&quot; technology, but they get even more skeptical if you tell them something is X and it turns out to be Y down the road. That (rightly) sends them on a fishing expedition.