Your question implies that the FDA will not lift t

Your question implies that the FDA will not lift the hold. The FDA is specifically looking at possible myocardial events. With over 1,500 patients any pattern of such would have become apparent well before now. The FDA may not trust data from Amarex but there is safety data from before and after Amarex. In addition the Amarex data is unnecessary . The raw data from trial sites and the DSMBs can be compiled.