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announced that the European Medicines Agency (EMA) has classified PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). Tetra Bio-Pharma Receives Ema Orphan Drug Designation for A Novel Topical Therapeutic Containing Cbd The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV) and weight loss and severe nausea in people living with HIV infection. REDUVO™ remains a top priority and the Company is ready to launch manufacturing activities as soon as possible following regulatory approval. The Company is in discussions with Health Canada to address final commentary on the submission. On December 30, 2020, the Company submitted its first New Drug Submission (NDS) for REDUVO™ to Health Canada to obtain a Drug Identification Number (DIN) for the prescription drug. Any company that intends to distribute pharmaceutical drugs in Canada must obtain a DEL as per Health Canada regulatory requirements. announced it has completed the Annual Licence Review process for Health Canada Drug Establishment Licence (DEL) and meets the regulatory requirements of C.01A.009 of the Food and Drug Regulations to maintain DEL for the distribution of pharmaceuticals, like REDUVO™, in Canada. No cash balance or cash flow is included in the calculation.Tetra Bio-Pharma Inc. Please note all regulatory considerations regarding the presentation of fees must be taken into account. Backtested results are adjusted to reflect the reinvestment of dividends and other income and, except where otherwise indicated, are presented gross-of fees and do not include the effect of backtested transaction costs, management fees, performance fees or expenses, if applicable. Actual performance may differ significantly from backtested performance. Further, backtesting allows the security selection methodology to be adjusted until past returns are maximized. Since trades have not actually been executed, results may have under- or over-compensated for the impact, if any, of certain market factors, such as lack of liquidity, and may not reflect the impact that certain economic or market factors may have had on the decision-making process. Specifically, backtested results do not reflect actual trading or the effect of material economic and market factors on the decision-making process.
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Backtested performance is developed with the benefit of hindsight and has inherent limitations. This information is provided for illustrative purposes only. No representations and warranties are made as to the reasonableness of the assumptions. Certain assumptions have been made for modeling purposes and are unlikely to be realized. Changes in these assumptions may have a material impact on the backtested returns presented. General assumptions include: XYZ firm would have been able to purchase the securities recommended by the model and the markets were sufficiently liquid to permit all trading. Backtested results are calculated by the retroactive application of a model constructed on the basis of historical data and based on assumptions integral to the model which may or may not be testable and are subject to losses. The results reflect performance of a strategy not historically offered to investors and does not represent returns that any investor actually attained. Backtested performance is not an indicator of future actual results. Disclaimer: The TipRanks Smart Score performance is based on backtested results.