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March 12, 2014, Wednesday, 05:36 GMT | 01:36 EST | 11:06 IST | 13:36 SGT
Contributed by Millennium Traders


Josh Hardy, a 7-year-old first-grader from Fredericksburg, Virginia, has survived four rounds with cancer and remains in critical condition in an intensive care unit in a Memphis, Tennessee hospital. a bone-marrow transplant made him susceptible to a potentially fatal adenovirus which is ravaging his small frail body as he endures heart and kidney failure. Josh vomits blood several times an hour as his family remains at his side, holding vigil over what could be the remainder of his very young life.

Biotech firm Chimerix, Inc. (CMRX-Nasdaq) has an experimental drug, Brincidofovir, that could potentially save the boys life through "compassionate use". Chimerix is reluctant because doing so will hamper the company’s efforts to get the drug to market in a timely fashion, thus potentially helping many more patients. Todd Hardy, Josh's father said, "Our son will die without this drug. We're begging them to give it to us."

Brincidofovir is a drug in testing stage but, Chimerix would need to go through an elaborate process with the U.S. Food and Drug Administration to get the drug to him under the FDA’s “compassionate use” guidelines. According to the FDA, if someone has a serious or immediately life-threatening disease and have tried but failed other available treatments, they can ask a drug company for an experimental drug, one still in testing stages, that has not yet been approved by the FDA. During fiscal year 2013 the FDA approved 974 compassionate use arrangements. Brincidofovir is not expected to be approved for sale until at least 2016.While some pharmaceuticals say yes to “compassionate use”, many others say no.

Kenneth Moch, Chief Executive for Chimerix said he would feel absolutely horrible if Josh were to die, but says if he helps the boy, it could hamper his ability to help many more patients down the road. Brincidofovir is in phase-three clinical development. Moch said, “As we progressed to larger and more complex safety trials, we made the decision two years ago to stop the program and focus resources on earning FDA approval.” There's no way he's going to give Josh this drug. Chimerix previously granted compassionate use for Brincidofovir in connection with testing programs conducted from 2009 to 2012. Chimerix reported that other children treated with Brincidofovir had their adenovirus clear up within two weeks. Officials with Chimerix said they do not have the manpower to properly process a compassionate use case. Additionally, the 50-person company based in Durham, N.C. are concerned it would open the floodgates for many more such requests.

There are planned protests for Chimerix to reconsider and give the drug to Josh. Executives reported receiving death threats in connection with the case.