markhughes.As far as I am aware, a sponsor of a trial, by...

markhughes.
As far as I am aware, a sponsor of a trial, by definition, includes not just the originator of the trial, but also those with an economic interest in financing it. In certain circumstances, a Company may wish to conduct an interim analysis of a clinical trial under a "need to know" basis. Surprisingly it is not mandatory to consult the FDA first , but it is certainly advisable to do so , since they will want strict protocols to be observed.

https://www.fda.gov/media/75398/download

An example of such an interim analysis is provided by a case study involving Abbot Laboratories for which I provide a link.
https://www.contemporaryclinicaltrials.com/article/S0197-2456(02)00275-1/fulltext

At the last results briefing, SI referred to the potential to access interim read outs. He specifically mentioned that many previous CLBP trials undertaken to date by competitors, were of only 16 weeks, or 12 months duration and the primary endpoints were linked to a reduction in pain ( as opposed to both pain and function in the MSB trial).. He obviously believes that potential investors might be willing to finance commercial roll out based on the 12 month results.
As to my claim regarding the current value of the CLBP IP , I suggest you look at the Eli Lilly-Pfizer transaction on osteo arthritis .
https://www.thepharmaletter.com/article/latest-tanezumab-trial-in-patients-with-oa-highlights-safety-concerns
Note the 16 week safety analysis conducted...but you may be interested to learn the licensing terms which were agreed in advance. $200m upfront with over $1.6bn of commercial milestones agreed back in 2013 many years before clinical trials were finished .
https://www.benzinga.com/general/biotech/19/04/13570340/eli-lilly-pfizers-non-opioid-painkiller-faces-safety-efficacy-concerns

Then look at the valuation of Incyte...$17.8bn
Incyte (NASDAQ:INCY) is a large-cap pharmaceutical company. Most of its revenue is derived from a single drug, Jakafi. While Incyte also has an extensive pipeline, much of it is early-stage. As far as I am aware Jakafi has shown a considerable number of adverse effects during its clinical trials for aGVHD and in my opinion, (based on the expanded access programme and also historic client data from from JCR), it is very unlikely to match the efficacy of Remestemcel for gut and liver treatment in the adult and chronic aGVHD markets. Time will tell if I am right or wrong .
https://clinicaltrials.gov/ct2/show/NCT03616184

Ironically, no one on this thread acknowledges how important the use of proprietary 3D bioreactor "serum free" production will be to Mesoblast. By avoiding the use of 2D planar harvesting methods using FBS as a very expensive growth culture medium, I estimate the savings will be close to 95% of the previous production cost and the production time will be cut in half because there are less phases required to produce from the master cellbanks. Furthermore, the FDA will no doubt be delighted that bovine cross contamination issues can be ignored going forward. It also calls into question whether JCR will want to gain access to this much improved harvesting techniques ...I do not know the terms MSB (Osiris) agreed with JCR in 2013 regarding future IP technology transfer but the pharmacoeconomic implications for all MSBs treatments are profound.


Please do not rely on my opinions when making an investment decision. All information and opinions are provided in good faith, but I make no representations as to its accuracy. GLAHs.