Clinical trials data20 Apr 2019 13:14
Just been reading back through Revive 1 and 2 results. No mention whatsoever about liver concerns. From Revive 1 “No significant differences were seen between treatment groups in mean values or mean changes in other routine serum laboratory parameters, urinalysis results, vital signs or physical examinations during treatment.” So, that to me means, no significant changes in LFTs(liver function tests), nor physical examination of the patient, so no liver pathology/toxicity.
This does really me make me wonder if this is just a massive cock-up by the company in not providing the sufficient data on LFTs during the trial( which they should now easily be able to provide to the FDA as these were clearly obtained during the trial). Or possibly there has been very minor rises in liver enzymes that are not clinically significant and they are trying to get a “clean label” and not have this in the drug information pack, when in reality many drugs can not be used or should be used “with caution” in probably older patients over 65s with liver disease, so this is not a barrier to the licensing of a drug.
If this has been the case this will gradually( or not so gradually!) re-gain the losses in SP, so might not get back to 40p before next FDA decision but could easily get up to 20-25p as June 3rd approaches