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clock Created with Sketch. 26/04/23
13:40
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Originally posted by otherperspective:
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Mesoblast is tantalisingly close to the finishing line with its BLA resubmission for steroid refractory acute GVHD….but without appropriate cash it was fast becoming uninvestable. Anyone following the fate of Gamida Cell’s recent fund raise will know how brutal capital markets can be in extorting a heavy price from companies who seek capital during bear market conditions...almost regardless of their prospects. Trapped in the twighlight zone, having passed Day 60 (Refusal to file risk )...then Day 74 of its submission and with the PDUFA date of the 2nd August fast approaching ..things are just about to get very interesting for shareholders. Based on normal periods of notice I would anticipate the Pre Approval Inspection (PAI) inspection to be conducted in Singapore in coming weeks. Mesoblast must be very close to also receiving more formalised feedback on the full review process…whether it be in the form of the FDA Mid Cycle Communication …which occurs about 2 weeks after the mid cycle meeting…or from other discussions around potential labelling or the need for REMS or any additional PMR or PMC (post marketing requirements or commitments).post any approval for Ryoncil, I believe the outlook for the share price will change materially and decisively. Firstly, i believe that any approval will trigger large milestone payments from the likes of Novaquest & Oaktree which will leave the Company flush with more capital . Secondly, the prospects of selling the European rights for sr AGVHD will be a walk in the park post approval . I also believe analysts have materially misjudged gross margins on the first few years of sales of Ryoncil as inventory write downs should allow rapid cash recovery from existing stocks. Thirdly, i consider the potency assay for GVHD will be also relevant to the pathophysiology of Crohn’s and UC ..as already evidenced by Takeda/ Alofisel . This should allow opportunities to fastrack SNDAs for refractory patients suffering from these conditions post results of phase 2 studies.
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I certainly share this sentiment - "The stench of market manipulation surrounds us but we will have to grin and bear it as a “necessary evil” whilst we stay focused on hopefully bringing the Company over the finish line…where we should all be handsomely rewarded !"
(20min delay)