The regulatory framework isnt as simple as that. You cant just do another trial and expect approval.
The FDA monitors such events. The fact of the matter is that there is a low probability of approval now.
Alchemia even states that they put in place adequate controls to monitor process and procedures with the assistance of the CRO.
There is a glimmer of hope if they can explain the Russian anomaly. But they cant..to date. Investigating this rubbish is some other company's job in my opinion. Alchemia should be focused on reducing opex and paying dividends. At this point I dont think they should be keeping staff on, just to flog off the other programmes/assets. They can do that later. Just get rid of 98% of everyone and pay-out. Its such a simple thing to do but they are hanging on for some unknown reason.
ACL should try to replace Russian 3rd trial result with new other country's trial result, page-3
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