disallowed....one poster makes some ill informed comment and you want to amplify this nonsense at the open of trading today. Hmmmm. “It will be an impossible task for MSB to protect its patents” Really. Perhaps you should tell this to Takeda who had to settle in its patent dispute with Mesoblast...or alternatively have a look at the Garnet vs Athersys patent infringement case. I am not a patent lawyer but in my opinion Mesoblast ensured its patents were rock solid by the purchase of Osiris back in 2013.. when certain IP protections dating back to 1990, originally filed by Arnold Kaplan in 1994, were granted .
Should Athersys successfully navigate its way through its current phase 3 trial for which it is only just currently enrolling, I know who i have my money on. Athersys licensed its core IP from the University of Minnesota back in 2002 so they will have a sensible defence...but it will not nearly suffice in my opinion. Several substantial companies have paid up front sums for Meosblast’s IP. Tasly, Grunenthal, Takeda, Hercules , NovaQuest & Cephalon, etc.,will have all conducted extensive due diligence on patent enforceability...so they do not share the insight of “Rogro 77” on disallowed. The Chinese may have utilised for compassionate use some stem cells supplied for medical research purposes to a hospital . This does not mean that there has been any “heist”...nor does it suggest that IP law can be flouted without consequences. Mesoblast is totally in the driving seat in terms of enforceability, in my opinion.
Since Athersys has been conducting Phase 2 trials on ARDS, it does not surprise me that they have received a fast track designation by the FDA and recognition by BARDA. Shame they do not have the benefit of fully blinded safety data from three phase 3 clinical trials to support their case...unlike another company i know. Let’s see if BARDA say anything about Mesoblast’s therapy in due course ! Remember, Mesoblast has both the patents and clinical data from Phase 1 &2 clinical trials for COPD to back up its claims. Imbruvica was the first company granted fast track status for its chronic GVHD therapy but that does not mean Mesoblast will be unable to show superior efficacy for its own therapy in the current investigator led trials being undertaken by Prof Joanne Kurtzberg.
It might be logical to speculate that Mesoblast’s recent announcement on Covid 19, is a precursor to confirmation of fast tracked clinical trials across many continents. Let’s save the world and worry about the legalities next month. If i was BARDA, i would want to know what ability each company has to scale up production immediately ..... in the case of Mesoblast...all that information has been garnered in painstaking detail with audited production runs as part of the manufacturing module of the current BLA application.
In the meantime , I note that Kenneth Borow , Francis Pangani and CTSN investigators from the Icahn School of Medecine are participating in Session 1003 “Understanding Disease to Guide Therapy in Heart Failure” being held on March 28th 2020 at the World Congress of Cardiology in Chicago. Their 11.00 am slot is to discuss whether “Mesenchymal Precursor Cells in LVAD recipients: Does HF ethology make a difference ? All debates will be virtual weblinks since the Covid 19 is distracting all the worlds cardiologists right now... will have something pertinent to say at such an important forum ?
Lastly, people need to be realistic. On one hand, virtually all biotechs burn cash and require constant refinancing. This is why shorters find it so easy to unsettle investors during times of extreme market volatility. However, Remestemcel is most likely to receive, in less than 8 working days, “priority review” for its BLA application. This will then provide certainty in terms of timing of short term cash flow and finally shut up all the armchair critics. Many of Mesoblast’s competitors have financed long and expensive CHF clinical trials (such as the SGLT2 trials) each involving up to 10,000 patients costing billions of pounds...some fruitcakes on this thread appear to suggest that the current market cap of the company is fully pricing in current risk/reward even though the market cap is a fraction of the sunk cost just to undertake these trials. Remember, there are very few treatment options for severe back pain and grade 3/4 CHF. The latter therapies are blockbuster products...which will save society many billions on annual treatment costs. Mesoblast , has a current market cap of just under US$400m , which even in a market crash, totally fails to reflect the huge risk reward. The share price may not reflect fair value now..but it will shortly.
Please not rely on the accuracy of any facts or opinions expressed in the above post when making an investment decision . OP
MSB Price at posting:
$1.16 Sentiment: Buy Disclosure: Held
(20min delay)