Obviously I have not seen the actual letter sent by the FDA, but what has been made public worries me. This is neither a conditional approval nor a standard 'approvable' letter. The former would usually
involve postmarketing studies, the latter usually involves negotiation of labeling and such. A "potentially approvable" letter pending "information from ongoing studies which demonstrates that
Myotrophin is effective"....well, one could say that all drugs in PhIII are potentially approvable if they
show efficacy.
CEPH/CHIR's response is also telling: usually when companies receive 'approvable letters' they issue
a statement that goes something like 'we are pleased by the agency's decision and look forward to working with them to resolve remaining issues so that (product name here) will receive full marketing
approval.' Instead, Baldino/Williams greeted the semi-approvable letter with all the joy one might expect from someone receiving an anonymous package postmarked Montana...they are not certain that
this is not a Trojan Horse, that the FDA looks publically like it is working with them, but privately may have unreachable demands. The only good news is that the FDA is acting as if it will not demand
another full PhIII, the bad news is that they may have demands that cannot be met by the current ongoing trials.
Unfortunately, my impression thus far is that is letter is a Trojan Horse. It is designed to make it look like (for the benefit of Congress) the FDA is "potentially" receptive to Myotrophin, while in fact doing nothing whatsoever to advance Myotrophin towards marketing. This could stretch out indefinitely, unless the companies decide that they are going to call the FDA on it and state that the conditions are unmeetable..in which case the FDA can claim that it is CEPH/CHIR who are not doing everything they can to validate Myotrophin. It is appalling that the FDA waited til the very last moment to essentially leave the status quo in place, and it again reflects unfettered institutional hubris.
While I have written at length that Provigil is likely to be much more important to CEPH's future than is Myotrophin, the fact that Provigil's final marketing approval is still under negotiation (with the same Division of the FDA) means that the FDA is holding a hostage,which will restrict CEPH's ability to speak publically about this bureaucratic intransigence.
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