RE:RE:Not likely to see ANY "insider activity here" for a month +RevJames wrote: So here are the three events (corrected from 2) that might be imminent and which might be contributing to the recent surge (using Spectral's numbers for potential market size):
- the FDA approval of DIMI's IDE for home use (submitted late Q4 2020), which would allow that investigation/study to proceed (anticipated FDA approval in Q1 2022) [Market size once approved: US$2.9B in 2025]
- HC licence for DIMI (Acute and chronic dialysis (HD, HDF, UF) in hospitals, health care facilities and home) [Market size: $35-70M]
- FDA & HC submission of DIMI for peritoneal dialysis. [Market size: US$400M]
I think the Year end F/S and the associated MD&A might offer some important clues(catalysts even?). Last year, the results were released in March.
Possible goodies: Restatement of 2019 comparatives and 2020 to US GAAP indicating more progress towards a US Listing. Perhaps more clarity (revenue recognition discussion) on the non-refundable cash that Baxter is providing to Spectral re: the Tigris Trial. Perhaps an update on how the Covid Study is going? Perhaps an update on the pace of enrolling Tigris patients, now that they have taken mitigating steps to counter the slowdown caused by Covid (ie 4 to 5 more recruiting hospitals). The pace should also pick up due to US vaccine distribution efforts, and a declining hospitalization rate. Finally what about signs of an increasing order book for SAMI ?
The Main attraction is Interim Data release. The Co has suggested Q2 or Q3. Not all that far away !
MM