Remember Echo Therapeutics (ECTE), that wonderful little reverse-merger bio-dreck company formerly known as Sontra and so loved by Florida bucket shops, Uri Landesman and Mark Nordlicht? The firm issued a press release last week trumpeting yet another “successful clinical trial”. The headline reads (emphasis ours):
Echo Therapeutics Announces Positive Results of Clinical Trial of its Symphony® Transdermal Continuous Glucose Monitoring (tCGM) System in Patients With Type 1 and Type 2 Diabetes
Being a curious sort, your author decided to take a look at the details of the clinical trial. Not by reading press releases, but by actually looking up the study. But when is a ‘Clinical Trial’ not a clinical trial? When you cannot find it on Clinicaltrials.gov perhaps? A search of the Clinicaltrials.gov database, try it yourself here, yielded absolutely no hits (see here) for any studies sponsored by Echo Therapeutics (ECTE). Yet, the company cheerfully continues in its press release:
(Echo) today announced positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes. Data from the study confirm that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes. Echo also announced that it plans to conduct a study in critical care patients in the near term.
Quite tellingly, Echo uses the term “positive results” but does not once mention “statistically significant” results. Why? Read on…
Using over 2,600 Symphony tCGM glucose readings from the twenty (20) study subjects paired with reference blood glucose measurements,
A sample size of only 20 patients….first semester statistics anyone? For an 80% powered study and desired statistical significance, one should need at least 26 subjects, and likely far more (and if memory serves, central limit theorem would suggest 30 at a minimum). Which just might be why Abbott (ABT) is recruiting 32 subjects for one of its studies (see here). And why the other actual players in the Continuous Glucose Monitoring (“CGM”) business recruit far more subjects. For example, DexCom (DXCM) is recruiting 230 patients for one of its studies (see here) and Medtronic (MDT) is recruiting 150 in a study (see here), not to mention Roche (ROG VX) doing a study with 130 patients (see here).
Of course, it is much more likely that this most recent press release was just a way to gloss over the fact that the company just did another discounted stock plus warrants PIPE deal, see here, and that it has been over 13 months since Echo filed for 510(k) approval of its other product, the Prelude Skin Prep System, and over 10 months since ECTE management had expected marketing clearance from the FDA (read more here and here). Once again ECTE=Fail.