RE:RE:RE:RE:RE:RE:my take away's from the conference call.Thanks prokofiev! But, as a layman, I am still puzzled by the FDA denial? My recollection of the status is as follows:
The clinical trial treated participants who suffered from chronic balance problems from MMTBI, despite physical therapy. There was the low frequency sham (placebo) device and the device. The improvement between the sham and the device failed to meet the primary endpoint (although both both particiipant sets improved significantly compared to their prior physical therapy only), A conclusion was that the improvement was attributable to the "placebo effect" and/or the more intensive physical therapy.
If the foregoing is accurate, on what basis did HSM apply for FDA approval, and what will be done differently this time - surely any clinical trail must test for the placebo effect?
prokofiev wrote: There is not much to talk about until we hear (1) about the European or Australian approvals (new markets) (2) the first meeting with the FDA post the rejection ((3) new canadian clinics opening (ramp of existing market)
All the information from the rejection has been digested, and it now all hangs on the three items listed above.
FDA
If they only have to redo a physical therapy only trial, the stock will likely rally. If they have to redo the whole trial, this is not a positive.