I think that we may hear about the IND process very soon.
The recent capital raise secured funds to bring a phase 1 dose escalation study forward to this year. While there has been little commentary about the specifics of this trial, I believe that it will be conducted in the US and would therefore require an IND approval. I have no doubt that RAC management are aware that first-in-class (as well as best-in-class) drugs drive multi-billion dollar buyouts and so, being the first epitranscriptomic modulator and/or demethylase inhibitor in the clinic and on the path to FDA approval is a great start. What this also does is puts Bisantrene under the nose of many large pharmaceutical companies, which, depending on the trial initiation, may align very nicely with the strategy of marketing Bisantrene to big pharma later this year. Additionally, I speculate that the City of Hope may have some involvement in the running of this trial, as they have the infrastructure and knowledge necessary to complete this with high-quality precision and timing and a reputation of world leaders in this space.
Put simply, I think that a US-based P1DE makes sense strategically and as such, an update on the IND process may not be far off - only time will tell.
General Comments / Chat, page-3200
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