# Eden Research CEO on more regulatory approvals to come (LON:EDEN)

- Link: https://www.directorstalkinterviews.com/eden-research-ceo-on-more-regulatory-approvals-to-come-loneden/4121112984
- Published: 2023-03-30T15:40:28+01:00
- Author: Amilia Stone

**[Eden Research](https://www.directorstalkinterviews.com/company/eden-research-plc/eden.l)
plc (LON:EDEN) ****Chief**** ****Executive Officer Sean Smith **caught up with DirectorsTalk
to discuss the need for state approval, why California is one of the most important
states for their products and what else we can expect in terms of regulatory approvals
going forward.

**Q1: ****Sean, why do you need state approval, I thought you already had national
approval? **

**A1**: The way the US works is that there is one national level of approval which
is managed by the US Environmental Protection Agency and that basically covers all
50 states.

However, just to make life more interesting, each state then has its own regulatory
approval process, some of those I won’t call them ‘rubber stamps’ but there’s simple
reviews of the EPA decision and then there are endorsement or permit to sell product
and some of those states are much more rigorous than that. California would be an
example of that where it’s basically another comprehensive review, similar to the
one that EPA has done.

So, it is required to get both and, in most cases, you have to do the national level,
followed by the state level before you can proceed.

**Q2:The company has indicated that California is one of the most important states
yet you don’t have approval there at the moment? What does that mean exactly and
what’s the impact on your forecast for the year? **

**A2**: Good question, and probably the questions a lot of people following the 
story are asking, and it’s absolutely the case that California for both products
is one of the most meaningful states for us.

For Avalon in particular, the grapevine fungicide market in California is by far
the largest in the US, and of course for Cedroz, California is a major producer 
of a wide range of horticultural crops which, you’ll appreciate, we have a long 
list of crops for which we’re approved now in the US.

California is, as I mentioned a little bit earlier, one of the most rigorous states
when it comes to their assessments and for a very long time, California has a reputation
of having very strict environmental standards for good reasons. So, at the end of
the day, they run their own process.

We are in a programme they call the concurrent review programme, which means they’ve
done the bulk of the assessment work in parallel with the work that EPA was doing.
That doesn’t necessarily mean that we’re then granted approval immediately upon 
EPA approval, there is a process that they’re going through.

We are engaged directly with the California regulator, which is called the DPR, 
the Department of Pesticide Regulation in California, and we know roughly the timeline
they’re working to but  if I’ve learned anything over the last few years, I’ve learned
never to speculate too wildly on the pace of regulatory action.

So, ‘what does this mean in terms of our forecasts’ which I think is the question
a lot of shareholders will be asking.

It doesn’t really affect our forecast because over the years we’ve learned to be
very cautious about predicting the pace of regulatory action. So, whilst certainly
we may not realise the level of sales that we considered to upside in the current
financial year, this won’t cause us to revise our forecast downward.

What is frustrating is we know there’s a very strong pent-up demand for products
like this, even the regulators themselves confirm that’s the case. So, it’s just
a matter of getting there, it’s a matter of when, not if, and I know people might
want to ask me the question of ‘when will it be?’, I can only tell you that we expect
it through the course of this year.

Now, I don’t want to speculate too much more than that other than to say that we
believe we are fairly close but again, making these guesses is the way to set unrealistic
expectations. So, I do very much look forward to updating the market on when we 
do have the California authorisation.

In the meantime, we do have approval for both products in a good number of important
states like Washington state, Oregon state, New York state, even Pennsylvania and
Virginia are major producers of some of these crops. So, we are very much looking
forward to getting on with that and we’re working with our distribution partners
to do that.

**Q3: What else are you expecting in terms of regulatory approvals?**

**A3**: Well, of course, California is a big one and we’re eagerly awaiting that.

We are also going through regulatory processes in Europe at the moment and we are
expecting authorisation of Mevalone in what we call Central Europe so I’d consider
countries such as Poland, Germany etc. imminently. So, we’re hoping to have some
good news on that front I would say within the next 3-6 months but again, with the
same cautionary label that it’s very difficult to predict exact timing for regulatory
actions.

In parallel with that, we are going through this process with CRD in the UK so we’re
very much looking forward to having approval for Avalon in our home market which
will be very exciting. Of course, the number of hectares under grapes in the UK 
is growing all the time so it’s a very exciting opportunity for Eden Research.

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