Report and approval timelines23 Feb 2021 17:20
Only just had a chance to read through the report.
The report states that the 180 day questions for Chronocort were answered to CHMP on time during February. We now have some numbers to work with. At the 180 day questions, the "clock" stops. When the questions are answered the clock starts again.
The CHMP decision is given around day 210 (30 days after the clock starts) however, CHMP only meets once a month I believe (the last 3 or 4 days of the month).
As there is no time in February to have 30 days, we should expect the CHMP approval at the meeting scheduled for the end of March. I have already checked the CHMP agenda for February and DNL is not listed.
On the share price, DNL have an uncanny ability to release news on down days. Profit (or loss) has increased but this was expected and communicated in the January update, so I would expect some share price recovery with the rest of the market.
On Alkindi sales, UK and Germany increased by 20% AGAINST Covid-19 restrictions, so we should expect a big revenue boost when GPs finally start seeing their patients again (worldwide). Gross margin increased, if this is maintained, it may lead to beating profit expectations when revenues pick up (at least before Ditest development costs come out). The balance sheet shows that they have built inventories from £1.2m to £1.66m, this extra stock should help meet demand when the world starts to unlock. They also purchased a new capsule machine (hidden somewhere in the last annual report), so they have plenty of capacity to manufacture and now at an improved COGS.
Quite a lot to be positive about , we were expecting sales to be hit by Covid-19 and the company confirmed that in the January update.
If/when Chronocort falls into place, the business plan will be fully on course.
ALB