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Biotech / Medical : ProMetic Life Sciences

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From: axial	5/23/2018 10:44:58 AM
	of 250

Congress Approves Bill Giving Patients a ‘Right to Try’ Experimental Drugs "Under the bill, a patient is eligible to receive an unapproved drug if he or she has “a life-threatening disease or condition” and has “exhausted approved treatment options and is unable to participate in a clinical trial” of the drug. Sponsors of the bill said it could help people with cancer, muscular dystrophy and Lou Gehrig’s disease, also known as amyotrophic lateral sclerosis, among other conditions. [...] Patients will have to provide informed consent in writing before obtaining an unapproved drug under the bill. Manufacturers will have to provide the government with an annual summary of use of the drug, including “any known serious adverse events.” Nothing in the bill requires pharmaceutical companies to provide experimental drugs to patients who request them. Drugmakers sometimes turn down requests because they have only a limited supply or because they are concerned about legal and medical risks. To address such concerns, the legislation would shield drug companies, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in “reckless or willful misconduct” or “gross negligence,” or intentionally harmed a patient." ______________________________________________ How will this affect PBI-4050 and Ryplazim? Not clear -- but the market seems to like the news. Both drugs are well-advanced clinically, and "recognized" by FDA. Both are well-tolerated, with demonstrated efficacy and no Serious Adverse Effects (SAE). PROMETIC’S PBI-4050: PHASE 3 PIVOTAL CLINICAL TRIAL DESIGN FOR IDIOPATHIC PULMONARY FIBROSIS (IPF) FINALIZED Prometic has made no public comment (so far) on its reaction to potential use of its drugs in this scenario. It's undeniably true that both drugs could find willing users IMMEDIATELY. Jim

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