FDA protocols must share 50% of the blame for the "Roller Coaster"
By catering to the industry standards with regard to Phase III trials, that they be narrowly defined, it ensured that the company would "boxed in" to a finite conclusion, upon completion; a "binary event" was the goal. However, If these tests were given greater flexibility in curve fitting the endpoints, lifesaving methodologies would evolve sooner.
Absolutely. The failure of a drug during phase III that has been in testing for over 10 years and PROVEN to work in many instances is an indictment of the system of approval as set forth by design, by the FDA. However, one cannot fault a system whose credo, at its core is to prevent harm or injury to patients in the form of pain or discomfort or a shortened lifespan. I think had the company had the lattitude that it needed, other less scrupulous companies could visit great harm upon their trial participants. Human beings can never be nor should they be treated as guinea pigs. Hell, guinea pigs hardly deserve to be treated the way they do but nothing to date has proven as conclusive or effective as animal testing. The day is coming, I predict where it will be obsolete but were just not there yet. In the meantime, it should be noted that the clinical trial AS DESIGNED (and I place GREAT EMPHASIS upon that phrase), was "not even close" in our CEO's own words to reaching it's endpoints. That does NOT however, preclude a more specific set of criteria gleaned from the SAME collection of data to MEET or even EXCEED the end points set forth in the HEAT trial. This "technology" (I hate to describe it that way as it seems to do a disservice to it's elegance), has a multitude of iterations towards which our data can be applied, including but not limited to: dosage, frequency of administration, length of administration, temperature, heat delivery system (HIFU vs RFA), specific wavelength, age, race, and gender subsets. For the purposes of the FDA requirement, we chose a very narrow and specific. In summary, I remain confident in Celsion's technology, I do however fault Michael Tardugno for the manner in which he revealed the HEAT results. It could not have instilled LESS confidence in the company's investors nor bolstered the confidence of our very detrimental and opinionated population of shorts. If handled properly the stock might have fallen by only 40-60% as opposed to 80%