Monday, March 26, 2018 4:50:36 PM
I think you'll be pleased to see that there seems to be another typo in the release :) This line in paragraph 3: "The adult trial will now include patients 12 and over and our drug therapy will be used as an adjunct to the standard of care which will include biologists with the goal to improve outcome and safety to the standard of care existing therapies." I think they meant "biologics", referring to Humira and the like.
The inclusion of standard therapies in the trial, and the fact that Lodonal is being submitted for approval as an adjunct to standard therapies, and not as a stand-alone therapy, is probably a political concession to big pharma. But again, I'm curious to see if every member of both patient groups -- the control and the Lodonal group -- will stay on biologics for the duration of the trial.
If patients already aren't achieving remission on standard therapy, it will be curious indeed if they are forced to stay on them for the trial. But then if they do achieve remission once Lodonal is added, it will be clear in any case that it is the addition of Lodonal that brings about the remission.
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