@JohnWayne87 - I have been wondering the same. A while ago I suggested that an Announcement of ethics approval for the CF33 trial would come first - and that the Ethics Approval would be a strong indicator that FDA IND approval was imminent. My comments were based on the fact that Imugene announced each of the four Ethics Approvals they gained for PD1-vaxx, ahead of the PD1-vaxx IND announcement.
The first three of those Ethics approval announcements came out on: 14/7/20; 17/7/20, 21/8/20 (all of these were for Australian sites). The final Ethics Approval - for the USA arm of the trial - was announced on 3/9/20. The FDA IND approval came just 2 months later on 2 November 20 and just one month after that on 1 December they announced dosing of the first patient.
Assuming they follow the same pattern we would see Ethics Approval before we get the FDA IND Announcement. However - I suspect they are not strictly required to announce Ethics approval. Ethics approval on its own is not all that significant. It's only significant as one requirement for gaining IND status. Announcing the 4 Ethics Approvals for PD1-vaxx one after another was good communication on the part of the company, but it may not have been an absolute ASX compliance requirement.
Past behaviour is not an exact guide to future behaviour. For example - in the current PD1-vaxx Phase 1 trial the company announced the initial enrolment/patient dosing on 1 December and they ALSO announced the completion of enrolment for Cohort 1 (on 17 December), with approval for dose escalation coming just 35 days later on 21 January. So I suggested here on HC that we would not see an Announcement on dose escalation to Cohort 3 until around 35 days after we saw an announcement of final patient enrolments for Cohort 2. For that reason I was getting a little worried, because initial enrolment/first dosing for Cohort 2 had been announced on 12 Feb and it was starting to look as though Cohort 2 final enrolments had been delayed. However - not so! To everyone's delight, (well - maybe not the Shorters lol), the dose escalation to Cohort 3 was announced 2 days ago with no prior announcement that Cohort 2 enrolments had been completed. Assuming a similar 35 day gap from final enrolment to announcement, we can see that Cohort 2 enrolments were probably completed no later than 3 March. So - in retrospect - we can see that Imugene continues to set a cracking pace for the PD1-vaxx trial. Genuinely impressive. At that rate, they might achieve final cohort 3 enrolments by around 26 April and we could perhaps see initial results as soon as early June.
So - getting back to CF33 - we mayfind that IND approval for CF33 comes without a prior announcement of Ethics Approval - though I still think the Ethics approval announcement first is likely.
Looking back - the Announcement of 6 August last year seems relevant to me - "Imugene Receives Clinical Guidance from US FDA for Vaxinia."
In that announcement they state that "Imugene received guidance from the FDA on the development plan for VAXinia Phase 1 study design including feedback on part 2 of the study in combination with immune checkpoint inhibitors, the proposed patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study. In addition, the FDA provided further guidance on key aspects of non-clinical investigations and provided valuable feedback on studies required to support the Phase 1 development plan."
I'm thinking here of the "safety monitoring plan" required by the FDA, because we now know from Leslie's comments last month on video (see believeforever's post of 1 April) that the toxicology studies for CF33 were delayed because relevant labs were tied up with Covid-19 research.
Toxicology studies would be required for the safety monitoring plan and I'm sure for Ethics Approval also.
However she referred to that problem in the past tense and stated that a lab had been found which could do the work, so with the toxicology studies now done we might soon see progress on the IND status for CF33 - perhaps with a preceding announcement of Ethics Approval, but we may just get a silence on the matter followed by the IND Approval announcement.
Anyway - for anyone who has read all the tedious and probably pointless detail above and got this far - have a fabulous day!!!!!
Nothing is certain, but at this point I feel extremely comfortable about Imugene's progress and prospects. Delighted, in fact.
(20min delay)