 Super,
a question was raised in the Q and A whereby AA said that money was spent monies in 2024 on regulatory work for the insecticide, but he did not explicitly say that Eden had submitted regulatory papers in the US and the EU for the insecticide. Equally, he didn't say that they hadn't.
In the 13th January 2025 Trading Update RNS Eden wrote the following
"Investments, expenditure and other factors
Regulatory costs have been relatively high in FY2024 due to the costs associated with the renewal of Eden's three active ingredients in the EU, as well as costs related to the full registration of Ecovelex.
However, Eden has also invested meaningfully in the development of its product portfolio, both through advancing regulatory submissions (new formulations and label extensions of existing products) and also laboratory and field work to assist in the ultimate commercialisation of those products."
AND
"Outlook
The FY2025 revenue guidance is underpinned by the expectation of sales of Ecovelex being made under approvals similar in scope to those in FY2024, as well as growth in sales of Mevalone and Cedroz due to increasing market share and pursuant to approvals that have been received in FY2024.
However, there are several key regulatory and commercial milestones expected in 2025 that have not been factored into the current guidance, which could increase the Company's forecast revenue in FY2025. These include, but are not limited to:
· EU-wide approval of Ecovelex
· Approval of Esseva™ (Mevalone) in France for downy and powdery mildew
· Completion of commercial arrangements for Eden's insecticide product"
So that reads to me as though they anchor insecticide revenue expectations to commercial arrangements, not sales as a result of regulatory approval AND if this is correct, that would imply they either haven't submitted regulatory papers OR they don't expect approvals in time for 2025 sales. That in turn would imply to me that they have fallen behind as previously they have stated the possibility of insecticide sales in 2024. There may be exceptionally good reasons why we are where we are, but it would help to clarify this.
Page 5, 2023 interims
Link:
"We intend to launch this product as soon as practicable, with regulatory
applications planned for submission in late 2023 or early 2024, subject to the outcome of ongoing trials and data analysis. Pending a positive and prompt regulatory decision, we estimate product launch and first sales as early as 2024/25 in the US and 2025/26 in the EU." |
WO2024163899 - PESTICIDAL COMPOUNDS AND THEIR USE / Applicant(s) GREENLIGHT BIOSCIENCES INC [US]; UNIV MASSACHUSETTS [US] +
[00037] In some embodiments, the plant pest belonging to the order Lepidoptera is a species from a family selected from the group consisting of Nymphalidae (brush-footed butterflies), Danaidae (milkweed butterflies), Pieridae (whites and sulfurs) Papilionidae (swallowtails), Lycaenidae (blues, coppers, and hairstreaks), Hesperiidae (skippers), Tineidae (clothes moths), Sesiidae (clearwing moths), Pyralidae (snout moths), Lasiocampidae (lappet moths), Saturniidae (giant silk moths), Sphingidae (hawk moths), Arctiidae (tiger moths), Lymantriidae (tussock moths), Noctuidae (loopers, owlet moths, and underwings), and Plutellidae (diamond back moths).
[00038] In some embodiments, the Lepidopteran insect species is Plutella spp, optionally wherein the Plutella spp. insect is Plutella xylostella.
[00039] In some embodiments, the Lepidopteran insect species is Spodoptera spp, optionally wherein the Spodoptera spp. insect is Spodoptera frugiperda.
[00040] In some embodiments, the Lepidopteran insect species is Chrysodeixis spp, optionally where in the Chrysodeixis spp. insect is Chyrysodeixis includens (soybean looper). [00041] In some embodiments, the Lepidopteran insect species is Helicoverpa spp, optionally where in the Helicoverpa spp. insect is Helicoverpa armigera (cotton bollworm). [00042] In some embodiments, the Lepidopteran insect species is Helicoverpa spp, optionally where in the Helicoverpa spp. insect is Helicoverpa armigera (cotton bollworm) [00043] In some embodiments, the Lepidopteran insect species is Plutella spp, optionally wherein the Plutella spp. insect is Plutella xylostella.
[00044] In some embodiments, the Lepidopteran insect species is Spodoptera spp, optionally wherein the Spodoptera spp. insect is Spodoptera frugiperda.
[00045] In some embodiments, the Lepidopteran insect species is Chrysodeixis spp, optionally where in the Chrysodeixis spp. insect is Chyrysodeixis includens (soybean looper). [00046] In some embodiments, the Lepidopteran insect species is Helicoverpa spp, optionally where in the Helicoverpa spp. insect is Helicoverpa zea (tomato fruitworm). [00047] In some embodiments, the Lepidopteran insect species is Cydia spp, optionally where in the Cydia spp. insect is Cydia pomonella (codling moth).
[00048] In some embodiments, the Lepidopteran insect species is Trichoplusia spp, optionally where in the Trichoplusia spp. insect is Trichoplusia ni (Cabbage looper).
[00049] In some embodiments, the Lepidopteran insect species is Spodoptera spp, optionally wherein the Spodoptera spp. insect is Spodoptera exigua (beet armyworm.
[00050] In some embodiments, the Lepidopteran insect species is Spodoptera spp, optionally wherein the Spodoptera spp. insect is Spodoptera litura (tobacco cutworm).
[00051] In some embodiments, the Lepidopteran insect species is Spodoptera spp, optionally wherein the Spodoptera spp. insect is Spodoptera litoralis (tomato moth).
[00052] In some embodiments, the Lepidopteran insect species is Pieris spp, optionally where in the Pieris spp. insect is Pieris rapae (imported cabbageworm).
[00053] In some embodiments, the Lepidopteran insect species is Tuta spp, optionally where in the Tuta spp. insect is Tuta absolute (tomato leafminer).
[00054] In some embodiments, the Lepidopteran insect species is Helicoverpa spp, optionally where in the Helicoverpa spp. insect is Helicoverpa armigera (cotton bollworm). [00055] In some embodiments, the Lepidopteran insect species is Chrysodeixis spp, optionally where in the Chrysodeixis spp. insect is Chyrysodeixis acuta (tomato semi-looper). [00056] In some embodiments, the Lepidopteran insect species is Paramyelois spp, optionally where in the Paramyelois spp. insect is Paramyelois transitella (navel orange worm). [00057] In some embodiments, the Lepidopteran insect species is Lobesia spp, optionally where in the Lobesia spp. insect is Lobesia botrana (European grapevine moth). |
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