“Over 7 million patients in Europe are thought to suffer from...

“Over 7 million patients in Europe are thought to suffer from CLBP caused by degenerative disc disease 7,8,9,10, a disease which involves inflammation and degeneration of the intervertebral discs due to various factors like age, trauma or genetic pre-disposition. The lack of ‘cushioning’ as one of the major physiological functions of the disc in turn can result in spinal instability, mechanical stress and bony changes of the spine which finally cause significant pain and loss of function11. In addition, the inflammation of the disc can cause severe pain, which is poorly responsive to systemic pain treatment12. Most existing therapies do not address the underlying mechanisms of these changes and provide limited symptomatic relief. Patients would typically suffer for several years already at a relatively young age, without being able to sufficiently address their pain13. Invasive therapies, including surgeries like SPINAL FUSION, are sometimes a last resort for these patients, however, the limited evidence of their long‐term effects remains a matter of concern14. If clinical trial results from Phase II are confirmed, MPC-06-ID could offer a new treatment option to patients otherwise considered unresponsive to conservative therapy, which can provide relief for at least 3 years and aims to retain the natural function and anatomy of the disc. MPCs offer the possibility to support and promote the existing regenerative potential inherent in host tissues and are expected to deliver superior long term outcomes compared to purely symptomatic treatments15.”


grunenthal.com mesoblast clbp



@Bazsa

Excellent points. You have saved me the trouble of responding. Every time I correct our incessant poster, he totally ignores the facts presented and gives some delusional response…..he is happy to suggest that CLBP can be fixed with a $5 pain killer ….when almost half the patient population has already been prescribed opioids and has often failed for a least six months, all conservative care options. If he thinks I am making up the likelihood of surgical intervention he should read the following from the Grunenthal website (see link above ) .


Perhaps @Sector would like to phone up Grunenthal , who are one of the top two leading pain specialists for Chronic Lower Back Pain in the world and explain that they have the wrong information on their website….They would have spent millions on due diligence and then agreeing to pay up to $1bn in milestone agreements (including significant amounts pre approval ) to Mesoblast …and i think they know slightly more about moderate and severe back pain than @Sector

The arrogance is breathtaking. He totally fails to understand dosing and how it relates to Cost of Goods Sold…and then proceeds to tell us that the CLBP will be a “low margin” therapy ……when it only requires six million cells ….how on earth does he think JCR makes money on Temcell which uses many many multiples of this dose and has a regulated price !!!

It is obvious that the market has ignored the outstanding prespecified endpoint data shown in two important pre specified subgroups representing approx 72% of the Dream CHF trial . Would any of the shorting clowns provide me with an example of any Phase 3 RCT EVER conducted in a HFrEF clinical trial showing similar results in such a large subgroup relative to best available therapy ? Let Silviu move purposefully and respectfully, though the regulatory hoops with the FDA ….I actually believe even the FDA realise that religious doctrines pertaining to null hypothesis present a dilemma which would make a further trial pre approval morally reprehensible.

@IndexInvestor

The use of the word “legend” in my thread was of course in jest as it was in the past tense…I should have said “Living Legend” . A legend by the way has a double meaning as its definition can include being “notorious” in some modern dictionaries.
I prefer the old school meaning such as that referenced in the Cambridge Dictionary.

”someone who is very famous and admired , usually because of an ability in a particular area”
https://dictionary.cambridge.org/dictionary/english/legend

I am not in love with this stock …it has cost me far too much money for that to be the case. I have plenty of other good investment ideas right now I could easily switch my money to….but I do admire the guts and tenacity of Prof Itescu. On the occasions I have had the honour of meeting him , he has come across as a very driven , humble and caring individual of great character….who has an amazing insight into the field of Mesenchymal cell therapy which may be destined in the near future to advance medicine to a new level in treatment of conditions such as:

Diabetic / Ischemic Heart Disease …including Strokes

Acute Respiratory Distress Syndrome

Potentially allowing LVADs to be a destination therapy for those unable to receive Heart Transplants

An alternative treatment for CLBP which prevents ten of thousands of individuals committing suicide by overdosing every year as a result of opioid medications for degenerative discs

or saving little children from an agonising death from aGVHD who are refractory to steroids

or allowing patients who suffer refractory Crohn’s Disease to keep their intestines and dignity by receiving one treatment of our therapy to put them into remission .

If Silviu and his incredible team (not to mention the consultants and those whose IP is central to the therapies) succeed in just one of the above …they will be a “living legends” …especially to the millions of people that could potentially benefit ….as well as their families and friends.

I share your “beef” about primary endpoints…By way of example I am deeply frustrated that the primary endpoint did not exclude “changes to diuretic therapies” which was specifically excluded in the GALACTIC HF trial sponsored by Amgen NCT02929329 which was an event driven Heart Failure trial conducted around the same time counting significant hospitalisation events in the primary endpoint ..I acknowledge the Board needs a few fresh recruits…I agree the Chairman should buy some shares…I wish the Company had been more conservative with their finances , etc etc….but nothing can take away from the fact , that subject to the regulatory oversight of the FDA, we are tantalisingly close to a paradigm shift in medicine…OP



Disclaimer. Please do not rely on the words of a complete stranger when making an investment decision. I could be a chef. Do your own research .