Member Info for marik

Today the RNS amongst other things conveyed a level of confidence in Synairgen by Thomas Clarke/PDMR. Looks like things are heating up accordingly.

"Cineplex is burning through cash, and times are desperate ...."

@exapt, Cineplex are in a lot of trouble financially. They are also aware that the chances of them getting paid via damages are very small. As I suggested in one of my previous posts, Cineplex would do well to just receive the money outlined in the original clause and a very small amount of damages (if that).

Something has made Cineplex want to ask for alternative forms of damages via cross-appeal. Why? Because they know that chances of getting paid should the appeal be upheld are low. Secondly, it also suggests that the appeal from Cineworld isn't as clear cut as Cineplex initially thought and they've waited sufficient time since original decision to make the cross-appeal. My view is that there is a strong possibility that the higher court could award Cineplex much less than they are expecting and this latest move by Cineplex could be, IMO, a strategic move to potentially mitigate this by pre-emption.

GLA

If I'm not mistaken, this may not have been mentioned on this board. As mentioned by @MylesMcNulty tweet [1], the Avacta home page has been tweaked with preCISION becoming the focus. The two "latest news" items focus on AVA3996 selection and AVA6000 IND FDA approval. It missed three in between RNS on LFT.

1. https://twitter.com/MylesMcNulty/status/1486729430881816578

Found it! Here is Ophidians nice image from the new publication:

https://twitter.com/Ophidian18/status/1486747327813537800

Can't find his post on here, but where ever it is, credit to Ophidian ;)

A very interesting paper on AffiDX [1]:

"...the new anti SARS-CoV-2 S1 Affimer® technology has shown to improve the performance at lower viral loads by 2-3 Ct values compared with the 3 other antigen-based LFDs showing fitness for routine use to reduce infections when used in moderate-to-high intensity settings where high volumes of specimens are tested every day."

GLA

1. https://www.medrxiv.org/content/10.1101/2022.01.18.22269401v1
* caveat: data is from March–July 2021, so no inference to Omicron drawn.

If you dig a little deeper into the adverts, you get a glimpse of what is going on behind the scenes. I've posted this in its own thread:

The adverts for these positions make an interesting read and might be useful for PI's to have a closer look.

The advert for US Market Access Lead states that they will be looking at "government sales" amongst others. They go on to state that Ashfield Engage will also be involved in the role: "negotiate agreements, administer contracts, and maintain US government price reporting".

Head of Commercial Finance Role states that the role will be in "supporting the Commercial function through launch of our investigative candidate SNG001 into the US market, pending regulatory authorisations and approvals".

I'll let you make your own deductions.

GLA

1. https://www.synairgen.com/careers/us-market-access-lead
2. https://www.synairgen.com/careers/head-of-commercial-finance

The adverts for these positions make an interesting read and might be useful for PI's to have a closer look.

The advert for US Market Access Lead states that they will be looking at "government sales" amongst others. They go on to state that Ashfield Engage will also be involved in the role: "negotiate agreements, administer contracts, and maintain US government price reporting".

Head of Commercial Finance Role states that the role will be in "supporting the Commercial function through launch of our investigative candidate SNG001 into the US market, pending regulatory authorisations and approvals".

I'll let you make your own deductions.

GLA

1. https://www.synairgen.com/careers/us-market-access-lead
2. https://www.synairgen.com/careers/head-of-commercial-finance

You make a fair point @thinshins, It is looking positive from SNG and I am looking forward to the data release whenever it is.

No pressure on SNG to release data early, I just want them to get it right. So far they've been excellent in doing just that.

They are gearing up to focus on the AVA600 considering this on their front page:

"AVA6000 FAP alpha activated prodrug based on the pre|CISIONTM platform"

That should be an indicate what Avacta will be talking about on their roadshow.

We have a lot of positive news so far. The company a 25 person SG019 trial to validate the additional questions that are included in SG018 (a standard way to support approval and labelling). They are scaling up, as given by their job advertisements. The CEO and team who are conventionally conservative in their PR have been visibly bullish. They have visibility of data as well.

The data for this trial is for ~620 patients, significantly more than phase 2. It will require extra time to digest and make sense of. It is very important that data is fully analysed and the wording for any RNS and media is fully prepared, checked and double checked. For these reasons it's not critical that they release the results in the same timeframe as Manic Monday. However, they are approaching a point, where I feel that they are about to release the results.

I'm predicting it as I've said before, at anytime now (IMO). However, if it's plus or minus a few days or a couple of weeks I'd rather wait for very good news than mistakes.

Looking forward to what will be a transformational period for SNG.

GLA

The study (NCT05207293) will be used by the FDA to determine whether clinical outcome assessment is as intended when used during clinical trials and will support approval and labelling. It's for the EUA application, the pilot test interviews refers to something else.

@Winit, it's standard practice to submit a study of this kind for NDA or EUA, the number of patients varies (doesn't have to be 25). Just shows that SNG are gearing up for submitting EUA.

"Why interview 25 new participants..."

It's standard practice prior to NDA or EUA.

@Brand, I'm quite diversified and SNG represents a small portion of the portfolio, but non the less a very very interesting one as my average is low. So spent a lot of time reading and commenting on others.

"Synairgen’s global network will always be able to support the strategic vision of the company including a focus on short and long term launches and expansions."

Considering they have access to the data by now, to be talking about "short and long term launches" and "expansions" is quite telling.

"Yes it was well discussed at length by some of the most distinguished members of this board."

@Brand. That would explain it, I've been away from the board for a while and didn't get to see these discussions. The 25 person trial is good news as it's for the EUA.

@Brand, understood. But wasn't aware that they carried out a futility analysis.

@Brand, Why would they carry out post-marketing requirements after a futility analysis?