Thanks @Lopez. In highlighting the FDA’s collaborative approach in the latest announcement, the company might have tried to sound ironic, but I think equally it was trying to emphasise why it had “a high level of confidence” to refile their BLA. The journey was tortuous and torturous, but having now got to a whisker within the destination with what I would describe as an unassailable moat in their understanding of the regulatory requirement, it simply solidifies their position vis a vis competitors. The challenge now is to maintain it and capitalise it for other indications. As Tony Boyd noted in the AFR not long ago, a ton of R&D had gone into the business. We cian say a lot about big pharmas, the dilutive capital raisings and the narrow shareholder base, but I look forward to the possibility that one day, maybe the optionality will be so large and the businesses so cash generative that no takeover offers would be as good as a buyback on its menu of options. When I used to be a CSL shareholder, I was told at one point during an Investor Day presentation by the company that it had not contemplated a share split because there had not been a clamour for it by its predominantly retail shareholder base. That is an interesting thought.
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- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-391
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