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Replies to post #305361 on $Rig's Platinum Penny Alerts
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=128968613
FDA ACCELERATED APPROVAL & $USRM.
GUESS WHAT? WE DONT NEED TO COMPLETE PHASE 3 BOYS.
MYOCELL COULD BE COMMERCIALIZED AT THE END OF THE II/III STUDY WITH AN FDA FAST TRACK APPLICATION AND UPON APPROVAL IN MY OPINON.
IT'S A PIVOTAL STUDY: STRAIGHT OUT OF THE WORDS OF COMELLA IN THIS VIDEO.
Video about MYOCELL And Clinical Trials. MUST WATCH
"A PIVOTAL STUDY " Which means at the end of the study we could commercialize
Under the Cures Act, “regenerative medicine and advanced therapies” are defined so as to include gene therapy, gene-modified cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products that use these therapies or products
In a statement, Robert M. Califf, the FDA commissioner welcomed the act for establishing “a new program for the development of regenerative medicine products, an important and exciting new field that deserves this special focus.” Key elements in its provisions, Califf said, were an “enhance[d] … exchange of information among FDA, researchers and developers,” and the creation of a “research network and a public-private partnership to assist developers in generating definitive evidence” that could lead to quicker approval of therapies showing that they “indeed provide clinical benefits that are hoped for.”
The FDA will receive $500 million over 10 years to implement these programs.
Under the Cures Act, “regenerative medicine and advanced therapies” are defined so as to include gene therapy, gene-modified cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products that use these therapies or products, according to an “explainer” on the new law released by the Regulatory Affairs Professionals Society or RAPS.
In its current form, the Cures Act does not allow new stem cell therapies to forgo those Phase 3 trials, when many drugs fail. Instead, it says that regenerative medicine products, which include stem cell therapies, can be granted what’s called accelerated approval by the FDA.
Under that program, regulators can green-light a therapy without waiting on a demonstrated clinical benefit. Rather, they can rely on symptoms or other measures — what are called surrogate endpoints — that might indicate the drug is working; a cancer drug, for example, could be approved if it shrinks a tumor, even if it hasn’t shown yet it extends survival.
Treatments that go to market under accelerated approval are required to be studied further to ensure that they do in fact show a real benefit as they become available to more patients. The designation is typically used for therapies for serious or threatening conditions for which there are few or no treatment options, according to the FDA.
Potential upsides to Cures for stem cell research. One possible benefit of the Cures regenerative medicine provisions is that some high quality stem cell therapies that ultimately will be proven safe and effective would likely get to patients more quickly and help patients sooner. That’s a big deal. For biotech the major plus would be that they will have to spend less money to get therapies further in the trial pipeline. Since we as a field need stem cell biotechs to be successful in order for all of us collectively to help the most patients, the benefit for biotechs would likely yield some benefit for the field. Another possible plus here with Cures is the focus in the language on the need for standards for regenerative medicine, which have been lacking in the field.
Congress passes 21st Century Cures Act, boosting research and easing drug approvals
https://www.washingtonpost.com/news/powerpost/wp/2016/12/07/congress-passes-21st-century-cures-act-boosting-research-and-easing-drug-approvals/?utm_term=.51156066f53f
PREDICTION: FDA FAST TRACK APPROVAL NEWS COMING WILL SEND THIS STOCK INTO ORBIT.
