Tuesday, June 20, 2023 10:17:44 PM
They will keep shareholders hooked via their messengers with reasons such as tissue agnostic, Project Orbis, FDA first, Flaskworks, etc. All pointing to needing more time to submit and how it can be a game changer. But all of this is a cover to allow completion of ph 2 combo study. In the end, we will find out that they only applied to the UK and for GBM indication only once the ph 2 combo study is completed in 2024. And it will be quite disappointing.
Of course, the other remote possibility is that they already submitted the application in April and we may get approval news directly in the coming weeks (in July?). Even if I were to trust this theory (which is next to impossible), the longer this drags on into mid-to-late Q3 it becomes evident that nothing is submitted and that there is no intention to apply this year because they are waiting on ph 2 combo data. The reality is it simply does not take this long to prepare and submit an application regardless of the inexperience and bench strength you have within the team. And all these excuses about waiting on tissue agnostic, FDA first, Project Orbis etc is just crap.
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