| | | Good morning, Vietnam! PVCT management responded in a letter to the editor of The Street.com. You can access this letter by going to the PVCT site, then clicking "investors" at the top of the screen, and then "SEC filings." Here's the letter in the SEC filing:
"January 23, 2014
To the Editor:
We are writing in response to Adam Feuerstein’s article, “The Obsolescence of Provectus' Skin Cancer Drug Means Current Speculative Run Ends Badly,” published on TheStreet.com, January 23, 2014. In it there are several inaccuracies and omissions. For instance, he writes that “PV-10 is a diluted solution of Rose Bengal” that “can be purchased by the gallon from any chemical supply company.” In fact, the opposite is true. PV-10 is a sterile, non-pyrogenic, high-purity concentrated solution of rose bengal manufactured specifically for Provectus to modern pharmaceutical standards, under current good manufacturing practice (cGMP), by specialty contract manufacturers. The investigational drug product undergoes comprehensive chemical and biological release testing prior to use in clinical trials. Neither the drug substance nor the drug product are available for third-party purchase from any commercial source and both are of markedly higher purity than commercial dye-grade material referenced by Mr. Feuerstein.
Also, counter to Mr. Feuerstein’s claim, the Company furnished a great deal of pertinent information through its independent press agent (not spokesperson) Bill Gordon that he failed to include in his article. For instance, Provectus CEO Craig Dees issued a formal letter on May 13, 2013 which included a "Regulatory Progress" section noting the ongoing process with the FDA and providing insights about options, delays and possibilities being explored. A link to that announcement is also available on the Provectus web site www.pvct.com.
We forwarded, as well, important scientific and medical announcements to Mr. Feuerstein, also omitted from his slanted coverage, regarding PV- 10. One announcement, issued by Moffitt Cancer Center on August 22, 2013, highlights how early clinical trials show PV-10 can boost immune response in melanoma tumors, as well as the blood stream. Another, issued by our company on September 30, 2013, highlights important analyses of data from the completed Phase 2 study of intralesional PV-10 in metastatic melanoma as presented at the European Cancer Congress 2013 (ECCO 17- ESMO-38 - ESTRO 32) in Amsterdam, The Netherlands. Both of these announcements are also available on the Provectus site for any readers interested in a more balanced view of the valuable work being done – and recognized – by Provectus on PV-10.
Perhaps most importantly, the company press release on December 18, 2013 clearly stated that our company held a Type C meeting (not an End of Phase 2 meeting) with the FDA on December 16, 2013 “to determine which of the available paths that Provectus’ novel oncology drug PV-10 will take in pursuit of FDA approval and commercialization.” This press release also referenced an important new regulatory path, breakthrough therapy designation, that wasn’t available in April 2012, the time at which Mr. Feuerstein implies the company went “mum” and after which our development program was purportedly static in the face of a rapidly changing commercial and regulatory climate. "
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