RE: My thoughts15 Aug 2023 09:43
Hi Digittt,
A couple of points in your post that i would challenge.
1. "The biggest unknown to me is how responsive the FDA will be"
We do know, the FDA are committed to responding within 30 days of receipt of the Hemo's complete response. Perhaps it is unknown whether it will be 7 days or 29 days. Given it is a single issue and one that has been described as relatively straightforward, i would wager that they get back within 2 weeks.
2. "I think the only tool Vlad will have is the first...ie badgering the FDA and getting them to respond."
Based on all the research I have conducted - 'badgering' or even simply 'contact' initiated by the sponsor is massively discouraged, I do not think badgering is professional; the FDA guidance is very clear and states a 30 days SLA
3. "how lucky we were with the equity raise early in the year"
I'm not sure i would term it 'lucky'. It was a Hemo decision to raise when they had the opportunity at a time when it was just as difficult to raise then as it is now, It would not have been taken lightly - but all small caps understand the huge importance of cash . The great news as a shareholder - it feels as good (if not better) decision now as it did at the time despite. (i appreciate some shareholders were upset at the time, but raises are part and parcel of investing in micro caps with high risk and reward)