To clarify:
There never-ever was a properly conducted trial before - this FDA trial is the first, and so far, the only one.
There have been two clinical studies - in/around 2010 and each on a very small number (combined total 20~24) of selected patients: https://hotcopper.com.au/threads/ann-interview-with-professor-keith-harding.1276506/
Note: Prof Harding subsequently pulled out and ceased to be involved https://hotcopper.com.au/threads/ann-excellent-clinical-results-and-manufacturing.1202013/
.......
I guess the above studies have been upscaled, reclassified and polished as phase 1 trials.
And that's what is regurgitated over and over again for comparison with the current *REAL* trial, both by TIS/FTT and HC posters, as the ultimate solution to all venous ulcers and the like.
But there is a caveat: Beware of the competition and the standard of care - seven years+ may have introduced some enhancements in the field of wound care.
From the Mid-Trial Update July 2017 https://hotcopper.com.au/threads/ann-clinical-trial-update.3536310/
see Page 12/13 -
Regarding patient enrolment: What happened at the Academic sites?
Referred to as good recruiters: What are the numbers? What happened? Quid-pro-quo not good enough? Too many unsuitable patients?
Regarding high number of patients eliminated (~65%) in pre-screening:
Whilst that may be a positive for the trial outcome it does narrow the applicability from both a medical and commercial viewpoint.
From Clinical Trial Update January 2018 https://hotcopper.com.au/threads/ann-clinical-trial-update.3967703/
Does not contain anything new in substance terms and is not exciting at all - Where Have All The Vibes Gone? (1*)
Page 5: VitroCARD Margolis 1 ???? - that's probably referring to the clinical studies conducted in 2010 - renamed and christened as MARGOLIS 1
(1*) Peter, Paul and Mary
Where have all the flowers gone?
Long time passing
Where have all the flowers gone?
Long time ago …
My main concerns:
Trial Spec's to narrow - may cause problems after completion of trial.
Silent dilution - issue of shares in lieu of payment may help in the near/immediate term but also signals to everybody that the company is in financial trouble.
A fund manager may look at the company in this way:
FTT's market value is, using a generous measure, nothing more than the third or fourth .... digit to the right of the decimal point on the balance sheet. On a Profit/Loss statement it would probably make it to the second or third or ... digit to the right of the decimal point - nothing more than a rounding error. Becoming a ten-bagger would not change this picture - therefore: No need to get excited, win or loose would not have any significant impact.
PS: I am still holding until the end - bitter or sweet - but unlike a fund manager treat this investment as a gamble - a win would get me a Maserati and a loss would not hurt me.
(20min delay)