Member Info for Matml74

Bundy, At least post something that is up to date. Morningstar is a load of ****e. It doesn't even have Polygon on there who have bought up 15% of the company in the last 6 months. Anyone that uses that website shouldn't be invested in the stock market.

Waite,

The FDA is meeting to discuss the Merck pill EUA tomorrow. If there are going to be games played with the share price it could be on the back of this news.

However, this comment in the Numis note is of interest....

"Indeed, we now understand that the UK Chief Medical Officer has doubts about Merck's Molnupiravir, although whether this is due to the new variant, the potential to be "supercharging new viral variants" (Source: Forbes) or the concerning mutagenic safety profile is to us uncertain."

If FDA throws out the Merck EUA application or significantly limits is use case then this may move the SP higher considering they already have over $2billion in orders with the US government.

First order from US will be more than that IMO based on their continued high hospitalisation rates and the emergence of variants with unknown characteristics. The easiest way to protect in this situation is with viral agnostic treatment. Not long now and we will know if that product will be SNG001.

Waite, The 35 day secondary endpoints complete around the 15th December and data will not be unblinded until then. Company has indicated toppling data early 2022 so that should be the expectation but recent events may help to bring that forward but that is a big maybe IMO.

Yes Saint. Looks like they added another 1%. I expect a tr1 early next week.

The 2 large trades at the end of the day tell you why we didn't. Price held at 180 to work these through.

https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-covid-19-pill-cuts-hospitalization-death-risk-by-30-2021-11-26/

Its highly likely considering COP26 was only a couple of weeks back.

It shouldn't really make any difference to efficacy outcomes. The efficacy of the drug depends more on the concentrations of INFB required to reduce viral loads and whether the delivery via inhalation can achieved those required concentrations. You can see from the data from the in vitro results for the three early variants (Whuhan, Kent, SA) they each variant required slightly different concentrations of INF B to reach undetectable levels.

The key is that the dosage that the lungs are receiving via nebulisation of SNG001 is much greater (approx 10ul/ml from memory) than these concentrations outlined in the in vitro experiments and is highlight below.

"In vitro experiments were conducted at Viroclinics-DDL in the Netherlands to confirm that SNG001 had activity against the B.1.1.7 (“UK or “Kent”) and B.1.351 (“South African”) variants. In these experiments, Vero E6 cells were treated with SNG001 prior to and after infection with SARS-CoV-2. 16-24 hours after infection, the presence of SARS-CoV-2 viral proteins was determined using an immunostaining method. SNG001 potently reduced virus to undetectable levels in cells infected with “Wuhan- like” (virus strain: Germany/BavPat1/2020), the UK/Kent variant and the South African variant. Concentrations, readily achievable following inhaled delivery of interferon beta, that gave 90% inhibition (IC90) were 3.2, 4.0 and 3.4 IU/mL respectively."

According to the protocol Activ-2 have a dmc looking at the data the whole time but as far as we are aware the A2-P3 has not started dosing yet.

Logically and within a pandemic, you would think with only a few data points to collect and all trialist's having been fully dosed in the Sprinter P3 the regulators would ask for an early unblind, particularly after day 28 as there is only the day 35 (intubation/death) data point needed which would only be for a handful of trialists at most.......... but unfortunately that is not how the system works.

Calm before the storm.

SG018 Sprinter trial protocol pdf.

Section 8.9 Interim Analyses for futility analysis details.
Section 8.1 - Sample size determination - The 300 patients for interim analysis is described in section

The protocol is from November 2020.

Also the Omnivision licensing deal as well.

Their partnership with Qualcomm on the snapdragon auto platforms will still see their tech and resulting licence revenue through the Chinese OEM's as I understand it. SEE just aren't engaging the Chinese market directly.

I assume he has made a mistake. They would just label the light blue as 'active' rather than 'visible' if that was the case. Maybe an email to the company would clear that up for you.

I will re-listen.

Glandore,

In relation to the second slides on page 11 in relation to 2027 numbers you mention. My take on that is that 'Visible' RFQ's are not necessarily all 'Active'. So they have 18m volume in 'active' rfq's currently being worked on. They know there is another 20m volume of rfq's that they have been told about but have not yet been asked act upon.

Let’s be clear on this.

The interim analysis happened after 300 patients enrolled on the trial. The company does not see the interim analysis nor do the regulators just the DMC and they decide to continue the trial or stop for futility.

The regulators don’t do their own analysis of the raw data, the company does that and will then notify the market of the result.

The regulators will review all the data once the company makes a regulatory submission for approval.

“. You name the reason for the SP dropping back off 12 this week, I'm all ears.”

Um, a placing at 11p might have something to do with it! I see no reason to be concerned with short term SP movements after today’s presentation.

Peel,

I doubt they will announce EUA approval with topline data as they would need to rns the application has been made before the readout.

Also consider that Parexel will be involved in the data analysis so expect this to be done more quickly that what occurred with the P2 trial.