https://www.sec.gov/Archives/edgar/data/1345099/000156459018022521/meso-ex421_530.htm@JB1975Tell you what JB . You do your comprehensive research and then tell Takeda/TiGenix they fluffed up agreeing a financial settlement and then we can compare notes. I would like to quote you the contents of Exhibit A and B of the TiGenix Court Case… but they appear to be confidential . Such a shame. Maybe you can see if Mr Troussel of Bird & Bird LLP wants to give you some free advice without breaching his confidentiality provisions ? They do charge a lot as they are considered the experts.. I believe they won their first patent case in 1909 .
https://chambers.com/department/bird-bird-intellectual-property-uk-1:34:11814:1:35
You are obviously highly proficient in this area as you have taken a punt with another stem cell Company, but you strike me as someone who is missing various pieces of the jigsaw puzzle.
If only you understood why the FDA changed their stance and were willing to look at the GVHD001 Remestemcel-L data in
isolation , as opposed to including the clinical data from the two older Prochymal trials conducted by Osiris ,which was manufactured at a different facility in the USA . The latter information was provided to Bell Potter post the RNS announcement and reference was briefly mentioned in a note to their clients shortly after) . I guess we will all have to wait until the final BLA approval (or rejection) and then such discussion will be academic . I suppose it’s difficult to work out the science when other confounding factors are at play (hint).
In the meantime, we will just have to rely on the assurances of our IP advisors until it is tested properly in a US Court…oh, I forgot , it already has been … but I understand the IP has been considerably strengthened since then ! Maybe you should provide your IP protection in this area. You show me yours…and all that. Must be frustrating as an investor to consider that, IMO, even in the extremely unlikely scenario that the BLA is rejected , Mesoblast still has a trump card to play against younger upstarts late to the party.
I guess even the mighty Novartis may have realised that too , but didn’t follow through with their proposed alliance when the ARDS trial was stopped for futility and the immediate need disappeared. All these missing pieces…very frustrating …and of course potentially very costly for those less advanced biotechs stuck waiting to commence Phase 2 trials . Remind me again , what explanation did Sumitomo DaiNippon Pharma give for dropping out of its takeover discussions with CYP after due diligence ?
In all seriousness , Mesoblast have no declared interest in prioritising diabetic foot ulcers which is a high volume low margin space well suited to pluripotent cell harvesting, (post long term safety studies of course) . I think the initial results look very encouraging . I note the absence of any Grade D patients in your initial sr aGVHD trial but creditable none the less . When one considers that meta data shows mortality rates of only 6% for Grade A and 12% for Grade B GVHD we must not get too excited by Overall Survival in this category of patients . Remind me again , do you cryopreserve your product ? OP
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