I tend to agree. We've now proven that it works. CYDY is requesting to resume CD12 it appears to increase the severe number if patients.
This may be for EUA, or it may be for full approval. We may get an EUA with a phase 4 confirmatory trial. We don't know what the FDA will decide.
There are also 194 other countries in the world. Do we really think 0 of them will give us an approval to sell?
As I see it the absolute worst case is that we have to add more patients in. It doesn't really matter if it's 50 or 250 as now that we have data we will enroll even faster than before. The number of cases may slow this down, but the awareness of our results should overcome.
I also want to remind everyone that once we sell our currently available product this company begins to transform. This is a long term play.
This may be for EUA, or it may be for full approval. We may get an EUA with a phase 4 confirmatory trial. We don't know what the FDA will decide.
There are also 194 other countries in the world. Do we really think 0 of them will give us an approval to sell?
As I see it the absolute worst case is that we have to add more patients in. It doesn't really matter if it's 50 or 250 as now that we have data we will enroll even faster than before. The number of cases may slow this down, but the awareness of our results should overcome.
I also want to remind everyone that once we sell our currently available product this company begins to transform. This is a long term play.
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