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FINANCIAL BENEFITS DO NOT GUARANTEE SUCCESS IN TRIALS: BIOMED XTL HAS BEEN GRANTED ORPHAN DRUG STATUS FOR AN EPO DRUG

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FINANCIAL BENEFITS DO NOT GUARANTEE SUCCESS IN TRIALS: BIOMED XTL HAS BEEN GRANTED ORPHAN DRUG STATUS FOR AN EPO DRUG

Biomed XTL announced today that it has been granted orphan drug status for the EPO drug it is developing. Following the announcement, the stock jumped 17%. Is the leap justified? While obtaining orphan drug status for the product may yield various benefits to the company, it does not indicate the chances of success in clinical trials. The drug is currently in preparation for phase 2 clinical trials, which are carried out on a small number of patients and are mainly intended to test the effects of the drug at different doses, as well as to assess its safety and the negative effects it has may have. That is, there is no telling at all whether the drug will work as the XTL expects.


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benefits during clinical trials and marketing benefits


However, if the drug receives FDA approval, XTL will have an exclusive in marketing the product for seven years. According to the Orphan Drug Act, this benefit begins from the moment the FDA is approved for marketing, unlike a standard patent, which typically includes the years of development.


In addition, a competitor who wants to develop a cure for the rare disease will also have to prove that its product is better therapeutically than the existing anti-doping, a burden of proof that does not exist in regular medicines. This constitutional situation creates a monopoly of the company that markets an orphan drug, for all that this implies.


Although obtaining orphan drug status does not indicate a possible success of the drug, it may facilitate the development of the drug by XTL, in that it may receive leniency in research and development of the drug, including tax breaks, exemption from paying fees to the FDA, and more. If phase 2 clinical trials are successful, the company may also receive easing of the number of patients required in Phase 3 trials,


which reflects the low incidence of the disease in the population. The great use of the word "made" in this context is due to the fact that the FDA can give the company any mix of the benefits mentioned, meaning that there is no certainty which of the benefits the Biomed company will actually receive. It should be noted that the drug developed by Biomed company XTL is intended for patients with multiple myeloma, a type of blood cancer. An orphan drug is a drug designed to treat such diseases, which affect a relatively small percentage of the population. In the U.S., a drug is defined as an orphan drug if it harms fewer than 200,000 people.


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what does it mean for the investor?


In conclusion, increasing the value of XTL resulting from receiving orphan drug approval is essentially potential at this stage. We as investors need to follow a number of factors: what benefits XTL will actually receive, whether the company will successfully pass the current clinical trials, what are the financial effects of these benefits for Phase 3 trials, and whether the Biomed company will be able to leverage these benefits to expedite the approval process or invest in other products

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