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The consolidated financial statements together with the report of our independent registered public accounting firm required to be filed pursuant to this Item 8 are appended to this Annual Report on Form 10-K. An index of those consolidated financial statements is found in Item 15 of this Annual Report on Form 10-K.
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“To rejuvenate is to forget “. Not sure about that one. In order to carry on into the future the brain handles to a large degree both life extremes of extraordinarily good and bad . For instance, it has been shown that if you compare a lottery winner with a recent quadriplegic, the lottery winner is initially ecstatic while the accident victim is depressed, but one year later the brain has equalized the events so well that both groups report an almost identical degree of happiness and life satisfaction . Neither group has forgotten the past events, but both are indeed rejuvenated.
Just in case you have overlooked it Josh and Greg Fahy have a published rebuttal in PNAS here: https://drive.google.com/open?id=1VcLlb0TXhlYZr38UQSgskOKm1Njva_68
Our lead product candidate may ultimately be regulated as a drug/device combination product. Third-party manufacturers may not be able to comply with the cGMP regulatory requirements applicable to drugs and drug/device combination products, including applicable provisions of the FDA’s drug cGMP regulations, device cGMP requirements embodied in the Quality System Regulation, or QSR, or similar regulatory requirements outside the U.S. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals,
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