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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0696+1.6%Nov 5 3:22 PM EST
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From: Howard Williams5/27/2014 5:14:42 PM
1 Recommendation

Recommended By
Khris Smith

   of 13111
 
The way I see it, the FDA said, "the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Therefore, designation as a Breakthrough Therapy cannot be granted at this time."

Their clinically significant endpoints are bleeding, infection and pain.

Not tumor shrinkage/eradication ...... the endpoints PVCT has demonstrated successfully, better than ANY other treatment, in PV-10 clinical trials.

Now lets look at what the FDA said about what PV-10 DOES do ......


FDA wrote:"We have reviewed your request and .... we have determined that treatment of “locally advanced cutaneous melanoma” meets the criteria for a serious or life-threatening disease or condition"

and

"The preliminary clinical data provided in your request for Breakthrough Therapy designation are indicative of drug activity in the treatment of local, satellite or in-transit recurrence of malignant melanoma."

I believe they're saying PV-10 will have therapeutic value in all melanoma stages. The ASCO posters should add more substance to that. All PVCT has to do is jump through the bleeding, infection and pain "hoops", and how they'll do that will be addressed on next Monday's CC too.

GLTA!
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