RE: Market12 Apr 2023 19:37
HT - Don't sink to the level of the few village idiots on here....
In answer to your question, given it's so close now, I will be very happy to get a through update from Hemogenyx as part of their annual report. That is it's purpose, for most listed companies, its the vehicle to get updates. It is due no later than in 12 trading days time, failure to publish would result in suspension.
Your comment regarding the half year report is lazy IMO. The timeline for for last 9 mths looks like this
July 6th - Vlad gave a detailed CAR-T update as part of an investor webinar. (available on YouTube). He laid out the H2 timeline, very clearly and fully transparently
July 13th - HEMO moves int new premises; this was pivotal allowing Hemo to manufacture their own CAR-T. The alternative will have taken longer and been significantly more expensive. As an investor, It's reassuring that Hemo took this decision and are in control of the quality of the cells.
est. August - Clean Rooms - ISO 7 Qualification required BEFORE Hemo could commence manufacturing
est. Sept - Model CAR-T Process Run - at least 1, probably more than 1. Vlad confirmed in webinar that Hemo scientists had been in Canada working on process development with Lonza with completing in July 23.
RNS - Hemo confirmed the completion of its 2nd and final SUCCESSFUL process run on 17th November
est. Sept to Dec - Plan was to conduct a minimum of 3 CAR-T engineering runs - a core requirement for IND. Each one taking 1 month consisting of: 12 days manufacture + up to 3 weeks of testing, analytics and reporting by both Hemo and a third party to prove to FDA that they are manufactured correctly and that they successfully kill AML cancer cells.
HEMO updated the market on the completion of each test:
RNS - 12th December - Hemo confirmed the SUCCESSFUL completion of its 1st engineering qualification run.
RNS - 4th January - Hemo confirmed the SUCCESSFUL completion of its 2nd engineering qualification run.
RNS - 23rd January - Hemo confirmed the SUCCESSFUL completion of its 3rd and final engineering qualification run.
RNS - 23rd March- Hemo confirmed the SUCCESSFUL completion of the full analytical tests by the third party. This was confirmed as the FINAL manufacturing step required to submit IND.
It was clear on 12 December that the final manufacturing step ahead of IND submission, the minimum 3 PQ engineering runs, was complete and that it would be at least a further 2 months before the minimum 3 mths would be complete.
It was not 100% clear whether the dates shared in July were the estimated/targeted date range or the period in which the whole task would be completed.; e.g Sept-Dec for minimum of 3PQ runs - could mean they expected to start in that period OR whether they expected to complete the whole task in that period. Open to interpretation.
Either way, in just 8 months, HEMO completed all the manufacturing requirements to submit IND and start clinical tri