Partial AGM Transcript23 Jul 2022 16:09
Transcript of YouTube Novacyt AGM Recording, - Question and Answer session only.
For those who like to have something to wordsearch.
https://www.youtube.com/watch?v=82EMwVn9QJ0
Q1
What is our current position in respect of the DHSC dispute?
James McCarthy answered:
I think the process will take some time, the core process isn't necessarily a quick process, however the company is confident of it's contractual rights in the matter and will continue to persue it.
Q2
The next question concerns IVD regulation, and what is the impact of this, and whether it is a threat or an opportunty for the business.
David Allmond answered:
The IVD regulation as opposed to the directive as it used to be but changed in late May, the company has taken great effort to be prepared for IVD-R. So from a clinical, regulatory and certification point of view, we are well position for complying with IVD-R requirements, and that we think gives a competitive advantage for Novacyt versus some of the smaller companies who may struggle to deal with the complexity of the new regulation, so we are well positioned to tackle that going forward. And it is important to note, that when we look at the strategy for the company, knowing very well that IVD-R will take them more time in terms of clinical developments and costs and regulatory filing to get new approvals from a notified body, that we would pick areas of high unmet need and opportunities for growth that fit strategically with the company. And therefore we took some time to do that with market research we've picked, we believe some areas of great value creation for the future in terms of near patient testing adjacent to the respiratory testing we've seen, and we've embarked on that journey. So the way we have steered Novacyt is that we are one of the medium sized companies that is capable of getting to the other side under IVD-R and being therefore competitive in that new environment. In the future we will also consider other regulatory jurisdictions that used to be seen as more complex compared to IVDD such as 510K with the FDA, and that means that from a regulatory standpoint we will be thinking - broad geographical opportunity as we progress the strategy, so we are well positioned I believe for IVD-R.
James Wakefield added - I think it's worth adding to that it's probably provided a very clear focus on what products we are going to be looking at and what we're not, and it's probably an opportunity for our (it will be a threat to some companies), but we are seeking to make it an opportunity and believe for these viral resources we can actually use this as an opportunity for launching new products.
Sign In
Follow the stocks
