Thanks for your non-abrasive writing on the current GALT/GR-MD-02 clinical trial scenario. No offense taken. Your reasonable train of logic may prove out, and if so there will be a cadre of disaffected persons driving spikes in the coffin.
My contrary defensiveness toward Dr. Traber et al. is grounded in the undeniable fact that there is an unmentioned but determinative presence in the scenario: the FDA 800-lb gorilla. The critics of Dr. Traber never reference that gorilla, as it would cloud and complicate matters.
It's a certainty that design of any clinical trial entails guidance from the FDA. Even a late-date modification of a cohort protocol in Phase1 was probably subject to FDA OK. You can bet your boots FDA guidance in designing the FX trial was welcome and held some sway. And all critical features of the protocol (eg. dosing, frequency) were scrutinized. Further, the design as an all-instrumental, non-invasive tissue-scanning set of methods may well have been a priority of the FDA, as such methods have been deemed highly desirable for validation in the diagnosis field. Had positive results been obtained it would have delivered major impact for both GR-MD-02 and non-invasive scanning. Of course the actual negative results mandate the CX trial to settle the matter. That's already in clinical progress.
As to GR-MD-02 dosing (8mg) GALT reported that quantity was deduced via high-end efficacious dosing (in mice) together with application of a mouse-to-human equivalency factor. My bet is that the validity of the deduction received FDA OK. Of course that doesn't make it optimal, I'm just saying the 8mg had received at least some scrutiny.
An amusing counter-scenario can be dreamed up, where Dr. Traber behaves like a Donald Trump and says he couldn't care less for any FDA blessing. He will add on a serum Alpha-2-macroglobulin test regardless of any subordination to tissue scanning. One wonders how that would play out. It's likely many shareholders would be irate, and Dr. Traber would be in hot water for alienating the FDA.
To my knowledge GALT never has provided a complete toxicity profile for GR-MD-02. For example, was an LD-50 (50% lethality)
established in mice? Also, what is the limit of solubility of the drug in the clinical solvent(saline)?
In any case the problem posed for shareholders (including myself)
I feel reduces to opacity, not fiduciary irresponsibility. Especially exasperating for me is Dr. Traber's avoiding explanation of critical decisions. However, that avoidance is somewhat understandable since full explanation would entail consideration of power relations within GALT plus superposition of FDA on top of that. People just do not like to be candid about power relations.
Some shareholders believe Dr. Traber et al. have not met standards of fiduciary responsibility, with depressed share value as proof. Such a charge may serve to scold or admonish outside of a courtroom, but I'd bet in a courtroom,especially with governmental regulations (FDA) factored in, a case for fiduciary irresponsibility would be a very tough proposition.
On this message board, a good, grounded, even healthful perspective on GALT has been written by Rickyricks (#2566 and #2597).
J.
AI
