My two cents -
Happy to be corrected where I have interpreted something incorrectly..
Pros:
- "Wow, wow, wow" - Dr T when referenced his reaction to COH paper
- Strategic partnership/deal expected second half 2021.
- Have had interest from Pharma, but they want further clinical evidence and are awaiting updates.
- Long term it sounds as though the board are focusing on whatever gives the holders the greatest return on their investment.
Cons:
- Another strategic directional change for Race Oncology. This is second since I invested only 14 months ago.
- I'm no longer expecting a trial to commence in 2020.
- Regulatory issues identified by CCSA with trial design - what are the issues?
- Still no update on the AML combination. Will the feasibility study just find that it isn't commercially in RAC interest to proceed with combination and they drop it? (I'm guessing the CCSA regulatory issues, changes in Nagler 2 trial commencement and not providing details of the combination are all linked).
- MRD trial put on the back burner. My understanding was this was the low cost, express train ticket item to approval, plus had a significant upside to patient survival. It's a shame that it is no longer a priority due to potentially greater commercial interests. If a raise of some sort was required to increase resources or anything to be able to also pursue the MRD pathway still, I would be in support of it.
- There wasn't really an update on what CCSA reported in regards to IND.
Further questions I have:
- Is the EM AML path going to be done as single agent? (I believe the feasibility study will suggest this route)
- Given that it could be used for approval under 505(b)(2) and also PNV, I'm assuming that this is single agent and will have to be completed in US and an IND is required.. How are we looking for the IND?
- When will we get an update on the feasibility study?
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- Ann: Race AGM presentations and strategic update
Ann: Race AGM presentations and strategic update, page-52
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