https://www.allens.com.au/insights-news/insights/2021/11/australian-class-actions-trends-2021-update/
Moving goalposts for securities class actions
“Securities class actions were the most common type of class action in Australia for over a decade, before they were overtaken by consumer class actions in 2019.
Australian securities class actions are based on the market disclosures of listed companies, with claims alleging a breach of the 'continuous disclosure' requirements and/or misleading conduct in respect of market disclosures.
In an effort to combat opportunistic shareholder class actions and the associated impact on premiums for directors and officers' insurance, the law relating to claims for damages in these types of claims was amended earlier this year, to introduce a requirement to prove the listed company acted with 'knowledge, recklessness or negligence’
While this change was welcomed by listed entities and introduced an appropriate fault element into the matters that need to be proved in a securities class action, we do not expect the amendment to significantly curb shareholder class action risk – it may, however, result in more securities class actions going to trial.”
Looks like the ambulance chasers will have to be careful with any vexatious claims. If there was any serious prospect of achieving success, would the class action in the USA have withered away?..I mean US$2m would hardly cover the legal costs of the US lawyers. The higher burden of evidence now required should make a much higher bar for successful prosecutions…particularly in relation to “forward looking statements”.
When this kerfuffle (spurious class action) first emerged against MSB in the US , I posted on HC that Mesoblast would be covered by Professional Indemnity Cover. The resultant agreed settlement appears pretty normal practice for insurance companies not wanting to roll the dice with the “wrong judge or jury” in the USA,where “inconsistent” legal interpretations have been known to emerge before often being overruled on appeal. Surely full disclosure of evidence was made in the US proceedings and any “knowledge, recklessness or negligence” would have resulted in a court case or much larger settlement ?
The US settlement shows also that our own PI insurers, who have all the evidence, did not find any grounds to invalidate our professional indemnity cover as they paid most of the bill.
SO , an unfavourable judgment would likely just lead to higher premiums for PI cover ?
It is obvious that the FDA is ludicrously short staffed . I read in one recent article that it was behind on 15,000 site inspections in the USA alone, largely because of Covid . I believe that Mesoblast will have meticulously followed the FDAs guidance in resolving CMC matters in the CRL…so i look forward to the BLA resubmission, although personally I believe early/mid July sounds a more sensible time expectation for its resubmission . This should also allow Philip Krause time to cast his eye over all the BLA paperwork .Once the BLA goes in, we will know within 30 days if our resubmission will be treated as a Class 1 (2 months) or Class 2 (anytime from 2-6 months) because we have “priority review” for an orphan disease. Alternatively there is a possibility, that with the safety and and efficacy modules (9-1 ODAC vote ) already opined on, we will just be given approval . I would expect the Company to commit to an adult Phase 3 study for sr aGVHD…but paediatric approval might allow label extension by use of SNDA’s for the multi billion indications of refractory Ulcerative Colitis and Crohns Colitis within 1-2 years. In the meantime, overlaps in pathophysiology might allow earlier “off label “ use, subject to further excellent results continuing in the Cleveland Clininc trials .
https://www.fda.gov/media/71856/download
In the meantime, Mesoblast have been pretty tight lipped about the “accelerated approval” pathways open to them for Chronic Heart Failure. Frankly, is it any surprise ? When faced with so many opportunistic ambulance chasers, I suspect the Board will be reluctant to update shareholders on many opportunities until decisions have been reached . In that respect, i would like the the shorters and any other miscreants,to show me any (nonMSC) therapy which has ever produced such a substantial reduction of three point MACE (a gold standard endpoint achieved in a rigorous Phase 3 RCT) as that achieved in the Revascor/Dream CHF trial. The closest “next best thing” I have come across in the meta data is the performance of GLP-1 receptor agonists which clocked up a respectable 14% MACE reduction…but@DocMcstuffins knows better ?
Whilst I am on the subject, all this bitching from certain posters about not using Hyaluronic Acid as a control in the planned CLBP P3, AFTER the FDA has already opined on using saline as a control, is frankly ludicrous. I fully appreciate the structural benefits of using hyaluronic acid and I am aware of its use with knee osteoarthritis but it is still an investigational therapy
https://cardiab.biomedcentral.com/articles/10.1186/s12933-021-01366-8
Frankly, the FDA, have been hoisted on their own petard for all to see. By their own admission, the AGREED use in P3 RCT’S of subjective patient grading or biomarker stratifications, such as CDAI for Crohns Colitis (excluding small bowel), NYHA Heart Classifications for CHF, or IBMTR gradings for sr aGVHD are ALL pretty useless, because they are out of date and inaccurate. Mesoblast is CONSISTENTLY achieving gold standard endpoints in mortality for Heart , endoscopic remission in UC/Colitis and superior overall survival in paediatric sr aGVHD which are overlooked in favour of far less accurate patient stratification. Almost regardless of which trial you look at, MSCs consistently prove to be superior is the highest mortality categories of Grade C/D and multi organ involvement . The fact that the approved adult therapy of Ruxolitinib for sr aGVHD managed only a 2% improvement over the control on an longer duration overall survival endpoint shows how “unfit for purpose” the current system of clinical trials is. Do not forget that the FDA were dismissive of dexamethasone as a treatment for ventilated patients for Covid until a large non randomised RWE trial in the UK put them rIght and they had to do an abrupt about turn and approve its use. The objection to retrospective MAP scores being used to calculate the null hypothesis in our BLA submission for Ryoncil is just another example of the idiocy of these people . Have they ever looked meta data of usingST2 as a biomarker in under 10s…nothing gets close in terms of accuracy… I could spend another hour ripping apart the FDAs own proposed potency assays…but it would not get me anywhere.
I recently read an edition of “Current Opinion in Hematology” where the penny is finally dropping;
”Several acute GVHD biomarkers have been identified, with some betterable to categorize patients based on their GVHD severity and potential forrefractory disease than standard clinical staging or response criteria.”
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2749563
As the above study shows (see link) , achieving “large treatment effect “ of around 2.5 times that achieved in normal P3 RCTs has historically allowed FDA to give approvals when merited. The fact is that the FDA has recently given “breakthrough therapy” designation to a Company which has completed a small Phase 2 trial using transendocardially administered BM-MSCS for CHF…but they were autologous cells” so certain “Doc tors” on this site, should not be fretting so much about the delivery method or MOA of our therapy . The FDA need to become comfortable on using allogenic cells in relation to potency , consistency and reproducibility. The Company claims to have that data …I believe them . Its been a long haul…the FDA have deprived us of a valuable therapy for too long. HUNDREDS OF THOUSANDS OF PEOPLE HAVE DIED UNNECESSARILY because this trial should have been stopped early…and the treatment made available for both ARDS and CHF….whilst confirmatory trials were planned. Unlike the black box warnings against so many recently FDA approved therapies ….MSCS have an excellent safety profile. To think that all currently approved Janus kinase (JAK) inhibitors indicated for the treatment of arthritis and other inflammatory conditions (this is the only FDA approved class of drugs for sr aGVHD) have recently had to add black box warnings…based on results from the ORAL Surveillance study of Tofacitinib.
https://pubmed.ncbi.nlm.nih.gov/35197363/
So, to conclude …I guess what I am really saying, is that the FDA should stop hiding behind a rule book that is so blatantly unfit for purpose. Even when a Company has inadvertently used a joint frailty model which trips over on an unexpected outcome from maintenance visits for diuretic therapy … the evidence from PRESPECIFIED gold standard data endpoints from Phase 3 data obtained over 6 year MUST surely take precedence ?. The FDA should use much more proven reliable biomarkers (supported by meta data with p values of 0.001) for patients in properly randomised clinical trials . They have approved a trial where hospital visits for shortness of breath from patients on diuretics have been allowed to totally distort efficacy data. In my opinion, this has been used as an excuse so far, not to approve the biggest advance in treating mortality for CHF in ischemic patients that I have ever seen . Thank goodness Prof Bolli and Eugene Brunwald , two of the most eminent scientists in the field , plus the FDA panel of Cardiologists, have seen the light and highlighted the ethical dilemma the FDA now face. Now we need to convince Doc McStuffins !
If you are listening Peter MARKS, you may have the best intentions ….but spare me the excuses. My concern is with the kids suffering from the horrific symptoms of Grade D sr aGVHD or the millions of diabetics whose lives could be saved. OP
Please do not rely on the facts or opinions expressed in the above post when making any form of investment decision. I am not legally or medically qualified.
(20min delay)