RE: Delayed FDA PK Study Response5 Aug 2021 20:22
Mike, the FDA wanted the PK study to be completed which delayed things by 5 months and Covid delayed everything for all pharma companies since March 2020! not just IMM and Avion. Avion and IMM have been in constant discussions with the FDA for the last year on the trial design, if the FDA had indicted in their December meeting that they wanted the Trial design to be different to what was proposed then Avion would have just pulled out there and then if they were not happy. They would not have gone to the expense and effort of doing the PK and all legal paperwork, hire new staff to work on this trial to then abandon it. In my opinion Avion want to be in full control of this trial hence the reason for the two company founders resigning from the board of IMM over the last few months, but crucially locking in their shares until the phase 3 trial is complete. If we get FDA approval and Avion set out their plans for the trial to start over the next few weeks and months this will fly to 20-30p imo such is the potential of Lupozor. We are talking about a multi billion $ market in the US alone, not to mention the rest of the world. Avion are no mugs, they are experts at working with the FDA and have had many drugs approved, Avion are willing to pay $25m for access to potentially licence Lupozor in the US whilst paying IMM $70m and double digit royalties on all sales. If they gain FDA approval once the phase 3 is complete IMM will be worth hundreds of millions, as I hve said before probably the only aim listed share I can think of that has the potential to 50 bag within the next 3 years if everything goes to plan…. Let’s see but if Avion believe in it then so do I
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