From a sheer numbers perspective, there are 23 million people in the US alone that suffer from CLBP.
CLBP is a unique condition in that it affects working age folks too and the lost productivity/workdays affecting bottom line for companies across all sectors is humongous. So it's not just a health issue but an "industrial" issue.
Some here suggested perhaps a better partner for Mesoblast would not be big pharma but an "outsider". I agree, at least in the CLBP space.
Yesterday, I posted about Eli Lilly's and Pfizer's Tanezumab and how they are targeting CLBP and Osteoarthritis using anti Nerve Growth Factors (NGF). Here some more perspective:
1. The FDA is desperate for non-opioid painkillers
2. The desperation shows clearly. Despite two prior clinical trial holds due to aggravation of the very problem Tanezumab was intended to solve, and despite adverse side effects, the FDA - and this is kinda comical and strange - lifted the clinical trial holds after a review of a robust body of nonclinical data. Yes, NON-CLINICAL data. Hmm.
Perhaps it is not really comical and strange keeping in mind the FDA's desperation.
3. HotCopper does not allow linking to this article, but you can Google "Tanezumab EP Vantage" and it is the first hit that comes up. It is an unbiased article about this space.
The author is not short or long any stocks mentioned and does even write about the share prices. Just lays out the science and compares various clinical trials and their progress.
The author is JUST NOT AWARE of Mesoblast's CLBP treatment. Surprise anyone?
4. Lilly and Pfizer may eventually get Tanezumab approved (they got the Fast Track from the FDA despite all the hiccups, so with their clout, I am pretty sure they will get this "approved"). But here is the thing:
Given the history of the anti-nerve growth factor agent means its safety will be under scrutiny.
5. Finally, here lies Mesoblast's grand opportunity since there is no competition. The opioid crisis is getting a lot of press and lots of dollars in federal grants. Mesoblast has to keep pounding on the FDA's doors to get the RMAT designation for CLBP. Full court press.
I am not sure what they are doing though. No one knows and I haven't seen any updates from the company on the status of their applications for RMAT. The CLBP opportunity is bigger than any other treatments that this company has in the pipeline.
It's thin at the top, Silviu. Get off your whatever and seize the freaking opportunity, coz no matter what, time is not an unlimited resource.
I am invested in this company not because of its management.
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