RE:RE:RE:RE:RE:RE:RE:results are goodInfinity wrote:
"Break through Designation is not only realistic, I think it is inevitable given the current data and comparable clinical tests being done in this area of research. Also keep in mind, this cure is not only effective, it is well tolerated and has the least amount of known adverse effects!!!."
Agree...& The FDA's responsibility is to protect public health by assuring not only the safety, efficacy & affordability of a treatment, but also that any treatment is based on "accurate" science. It seems the FDA would be obligated to take a much harder look at the "optimized" CR data in our route to either a BTD or final approval.
I'm also encouraged by the fact that we are getting such promising preliminary results with only 1 or 2 treatments. If this gets approved, I can also see TLT's less treatment-intensive & safer approach giving docs some leeway in their treatment strategy (i.e. provide an additional treatment) for the more treatment-resistant patients (i.e. partial responders) who have no contraindications to further treatment (i.e. no serious adverse event). This ACT is still in the investigational stages, & imo, there will undoubtedly be future modifications/off-protocol strategies to accommodate specific cases...that's what is called the "art of medicine", which can also be invaluable/life-saving. All imo. Good luck...