RE: One thing for sure IMO.2 Sep 2019 11:37
Morning Dracula, not sure that is altogether for sure. I would agree from PI trading volumes it appears both sellers and buyers are in short supply, but again we are seeing that shortage in volumes made up by bigger sellers and a big buyer. So sentiment has not harmed our buyer by definition.
Rather than sentiment I think we are all frustrated and unsure by the IND being delayed, we haven"t been given a reason, and that is because it is an issue between the FDA and Ichor, therefore by definition not one Scancell by protocol if nothing else can comment on. In contrast the European Approval had a different opinion and granted Approval at the end of April. It is IMHO that in those four months we have put into place a long list of to do items to begin the trial, and in the absence of the FDA IND we have decided to withdraw the application in the U.S.A to ensure no further delays to the U.K. arm.
Had we have received the IND back in July the question would be would the trial have been ready to go then. I don"t believe it would for the reasons given and therefore this supposed further delay has been caused by the FDA not Scancell. To alleviate the delay any further we have once ready to start the trial to wait no longer and ensure patients are dosed immediately after being selected, which I believe has been done for the first six patients.
Scancell will decide when they want to inform the market, whether that be patients selected, first patient dosed or all patients dosed. I further believe that being the case I hope we can notify shareholders by the AGM next Thursday week.
From what I have gathered from others the issue is we were not informed the trials had to start together, but I think we all just presumed they would quite rightly, but in reality because of the delay in the FDA IND, would the trials have started any earlier than now anyway?? We have been told the trial has started immediately, so I believe when we are told the patients have been dosed, which IMHO will be by the AGM, who will feel really feel aggrieved with Scancell for the FDAs delay??
This is just my opinion Dracula, it is one I have reasoned, and no I don"t believe Scancell have done nothing to prepare for the all go here whilst waiting for the IND to arrive. Do you really believe that is the case?? And I would ask anyone the same question. ATB