As we ran out of time I could not ask questions, but I spoke to Neil Frazer after the meeting for 20 minutes to get most answers. My recollection of the presentation and the private chat is as under:
Neil could not tell me about how phase 2b efficay results were looking as this was material information. He and Matt also said that htey had not started analysing the data, but were only aware of overall details. I wanted the answer badly and kept probing. Neil said that Interim EFFICACY RESULTS will most likely be presented in the fourth quarter. He said that these results would be company defining not because this would force FDA approval but give the world and indication of the product. These results are very critical as big pharma/US investors rely on data before jumping in. Neil was tight lipped, and his general comments and body language suggest that we will get very strong positive data (Please - he did not say anything directly). Later I got the same feel from Matt (separately). Please note that some patients in Phase 2b have progressed, but that does not mean that Cvac is not effective. There are various probabilities/end points to consider. based on his answers, my gut feel is that Matt would have not taken up the role if he did not have sensitive information about progress. I believe there will be a strong indication from Phase 2b results about its efficacy. But we will we have to wait for Phase 3 to get approval.
Neil confidently said that MR (MR has left) would continue to hold his shares as he did not want to miss the boat.
Neil was a full time employee of Prima and his role does not change.
Neil said that Martin Rogers had worked 20 hours a day for 4.5 years and needed a break after his marriage and was therefore leaving. MR did well with the cap raising and he was not pushed due to Nasdaq events. He said that MR was a good salesman and not the right person for the trials phase and agreed that he was often over-optimistic but Matt was technically competent and always closer to reality (he said something to tis effect).
Safety results - no problem at all. 5 agencies/groups are monitoring these and they would have stopped the trials if there was a problem. This is a non issue.
Boiler - we are not conducting a Phase 2 trial. It is a phase 2/3 trial. Phase 2 relates to the manufacturing processes and phase 3 relates to efficacy. This applies to FDA, EMA and TGA. FDA is happy with the tirals. The company expects to achieve the end points to meet FDA commercialisation requirements with this trial. That is the aim of the trials. If results are good, given the orphan drug status and no other cure, the chances of approval are good.
Canvas Uptake: Australia is currently screening patients for Canvas. Recruitment is progressing well with heaps of blood collection centres and treatment sites.
CAN-003X: This study will take all persons who relapse from both arms and treat patients with cvac and chemo. The results are important towards proving endpoints.
ICS: Results from ICS techniques to confirm our understanding of how CVac works biologically: Next few months
Neil thought development to scrap Dubai and Crypto were positive as this would save cash and time and focus efforts on the big reward.
Analyst coverage - I Spoke to the Ords guys afteer the meeting and asked them to put someting up.
SP falling: Are there any reasons/results to believe that CVAC may not be effective. Ian and Lucy said that there is no reason.
Sorry for typos. Lot more to write, but I need to get some work done and keep my job (atleast until the results put a rocket under the SP)
Goodluck - Brainy.
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