Ahmed Tejan-Sie MDUnited States
Aug 8, 2014
Today our petition has more than 53,000 signatures, a big thanks to everyone who contributed to attaining this. Yesterday the press reported that the FDA had issued a partial release of the hold placed on the phase 1 clinical trial of TKM-Ebola.
http://www.usnews.com/news/business/articles/2014/08/07/fda-lifts-hold-on-experimental-ebola-drug
According to the article on US News and World Report: “Tekmira said Thursday the agency "verbally confirmed changes to the hold that may allow the company to make the drug available”"
Also, Tekmira’s Chief Executive Officer Mark Murray said in a statement on Bloomberg News: “We assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so.”
This is quite encouraging; but we request further clarification on what this exactly means for TKM-Ebola drug research and development going forward. We hope to receive a more strident response from the FDA regarding this clarification and from Tekmira about their response to the FDA’s concerns. We also hope this will be done in an expedited manner due to the emergent situation at hand. Meanwhile we encourage everyone to continue signing the petition and forwarding it to as many people as possible.
Prior to this, your response had generated media attention with several interviews including one with Reuters news agency and TV interviews on WSBT Atlanta and the Canadian Broadcasting Corporation news:
http://www.reuters.com/article/2014/08/02/health-ebola-fda-idUSL2N0Q802R20140802
http://www.cbc.ca/player/News/ID/2482604307/
These efforts had elicited an earlier media response from the FDA:
http://www.wsbtv.com/news/news/local/fda-issues-statement-regarding-call-expedite-proce/ngtLD/
At this stage we will add another experimental drug for fast track consideration by the FDA namely Zmapp produced by Mapp Biopharmaceutical Inc. to this petition. This experimental drug was used on the Ebola infected American aid workers Dr. Kent Brantly and Nancy Writebol with highly encouraging initial results. At this stage it is prudent that it undergo the trials to determine whether the rest of humanity can benefit from it. The petition will be updated accordingly.
We also invite all other drug manufactures currently and previously involved in Ebola research to join the race - not for a county track meet but for the Olympic gold medal of making this the last Ebola epidemic without a cure or vaccine. Again, let’s save lives together.
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