From memory in that presentation SI indicated that the reason Hyaluronic Acid (HA) was used alongside Rex-L was simply to act as a
carrier molecule (and the FDA were on board with this). HA is not approved by the FDA for CLBP due to degenerative disc disease so it was inappropriate to do a head to head phase III clinical trial of Rex-L vs HA. This was clearly answered in the questions and answers part of this presentation (which unfortunately the Doc was unable to attend nor interested in putting his opinion regarding HA directly to SI where questions were able to be submitted online before the presentation). From memory numerous posters such as
@LearningEachDay have conversed many times with the Doc regarding these trial results and the Doc can not resist to bring up old discussions which have already been discussed at length. I still wonder why a non-holder would continuously bring up their same negative arguments on repeat (
their opinions without having access to insider discussions with FDA, experts on speed-dial, all data etc) year-on-year (and largely without acknowledging the benefit side of things). At the end of the day the FDA are charged with approving (or not approving) therapies based on their benefit to risk profile. I for one see minimal risk in our therapies (exceptional safety profile) with very encouraging/promising benefits in terms of health outcomes, slowing disease progression etc (sometimes with no approved alternative therapy or targeting unmet need) as well as lasting results with a single injection or short course of infusions. As a long term investor there has been no decisive argument put forward from the non-holding critics that will change my positive long term outlook for this stock. IMO the benefits certainly outweigh the risks at this point in time in terms of our therapies potential (and therefore an excellent chance IMO of an approval or two or three...). Like
@col69 I may change my sentiment if there are no near term approvals for Rem-L and SI is unable to secure a partner for CHF. This seems unlikely in my opinion so I patiently await life changing news.
(20min delay)