Member Info for Fruitsnveg

No, that's an incorrect interpretation Wigster. It is very much a scientific event which will be attended largely by specialists in their fields of ID and researchers which by definition includes TRIAL INVESTIGATORS, ORGANISERS, ETC....). For information, the ID specialist lined up to present SNG findings is himself a Trial Investigator.

The benefits of having findings presented here should be VERY obvious.

Morning All

About CROI 2023 :

"Abstracts are evaluated by the Scientific Program Committee and additional reviewers for the relevance of their topics, the RIGOR of their research, and the DISTINCT CONTRIBUTIONS they make to the broad spectrum of study that CROI strives to provide each year.".

What CROI is not is a membership society event, commercially driven, or a government funded event. It is not a pay for play event.

Polygon were "sucked in".
That's tickled me Axe. Imagine a hedge Fund with an army of astute research analysts and the biggest brains in Finance being "sucked in" with by the moronic baseless hype on a pithy LSE bulletin board, for 3 years!?
No?
Me neither...
Lol though xx.

Just to clarify...."Impatience" is the enemy of success!
Earlier statement was a St. Valentine's Wine induced typo :-)

Gosh you're a right hoot today Mani.

Just to remind you of your own statements a mere 8 weeks ago before you returned from having the personality transplant....:

You said
"1. TGF have added since SPRINTER
2. Key figures now discussing our Data.
3. Been "Invited" to speak at US Conference
4. Our LC results independently been acknowledged as significant.
5. ACTIV2 trial result... SNG001 should go to P3..
6. Significant roles advertised in last few months.
7. £20 Millionish cash in the bank....NO DEBT..
8. Patents in place.

We had a setback but our trial data is recognised as significant and warrants a further trial..
Patience will be rewarded here...."

Wow - fighting words Mani! As I never tire of saying, Patience is the enemy of success! xx

Wigster,
Not an SNG bod, he's an ID expert at Stanford ...." ASSISTANT PROFESSOR OF MEDICINE (INFECTIOUS DISEASES) AND OF MICROBIOLOGY AND IMMUNOLOGY" to give him his correct title. I assume he is presenting the findings.

"Things will probably continue on their drudgey interminable way in a week's time - into March and then April & May but without a big free trial (yes that one) - Synairgen's journey is most likely over."

Most entertaining Doc.Daneeka. At least we have June to look forward to, for the AGM and a full update from the Chairman, CEO and BOD. You forgot to mention June.

I notice the presentation before us lasts only 8 mins - there must therefore be a lot more to cover in our 40 mins Brand! Looking promising IMHO.

I was going to reply but then this little ditty popped into my head. No point in letting it go to waste on this lovely St. Valentine's day:

Roses are red,
violets are blue,
Axe is a shorter,
and so is Drew.

xxx

Manifesto, I challenge your statement that " EUA... if we did that would require a RNS and take months,". Holding pre-EUA meetings with regulators and building the submission paperwork in advance would not require an RNS. And there is evidence that it could take less time than you think to have EUA granted. It will not necessarily take months - there are cases where the opposite is true, where EUA was granted quicker than expected.

You say it is not justifiable to hire someone now, in advance of submission, that there will be "plenty of time to recruit in the hope we would succeed ". I disagree, there won't, and that's why other pharmas do the same by ramping up resources early in the schedule so they do the unseen mountain of work behind the scenes and then hit the ground running when a 'Go/No-Go' decision point is reached. That's not my opinion, it's fact.

Impatience is the enemy of success.

Manifesto,

It appears your concern is with hiring the AMAD now rather than later, when the regulators come to an EUA decision point? Hiring into such roles really is done months in advance of decision points - there is a very exhaustive list of work that needs to be completed to plan before then, it takes much longer than most posters on here realise. The information is out there, just google it. The company is actually DE-RISKING the chance of budget overrun by hiring proactively now in time for decision points, and in a typical pharma timeframe. Reactive hiring (i.e. only when the need has passed) would ostensibly cost the company, and therefore the shareholder, more. I don't see any issue with the hiring now, I view it as a positive sign. The hired person will not be doing nothing. Much work needs to be done BEFORE submitting an EUA, it's a key part of typical clinal trial project planning. Take a look at big pharma clinical trial timelines, staff numbers are ramped up well in advance of milestones, so they have adequate time to produce the vast array of documentation etc that is required to meet those milestones successfully. If anything, I think Synairgen are being very proactive. I do think they should update us soon (in the next few weeks), but that is a separate issue.

Their Irish solicitors lease is up/building being sold, so they are moving address I imagine.

Yes wpa, there must surely be a lot going on behind the scenes.

Interesting Gunto. It looks like they can help with a wide and diverse range of pre-commercial activities, not just hiring.

I wouldn't laugh if I were you Professional. I did as you suggested and visited the Ashfield Engage site, where in I found the guts of what is involved in pre-launch activities. It is an eye-opener. What part Ashfield, or the company plays in this list of activities doesn't really matter - what should stand out is the overwhelming amount of work required before launch.....here's a flavour:

"Despite all the changes in the market over the past two decades, one constant has been the ‘six-month rule’ – that being new products establish their success within those critical first months of post-launch.
Being well-prepared for launch is hugely important. It is essential to have the insights and strategy; messages; sales, MSL and patient-engagement teams all lined up and ready to go. Such depth of coverage stretches the resources of most, and having a partner with the capability to help hit the ground running is crucial to success.
An emerging biopharma client bringing its first product-to-market needed just such support. Using a consultative strategic approach we worked with the client to forecast, segment their customer targets, design their territories and size their sales force; build their data warehouse integrating more than 35 different data sources to support med affairs, market access, sales, marketing and trade/distribution; develop custom reporting and advanced analytics; hire, onboard and train a field and virtual field force; deploy an MSL team, develop and deploy a CRM; and conduct a national launch meeting.

For those who need a rapid build to launch, Ashfield Engage has the capabilities to meet global launch requirements. For instance, during the pandemic, one of our clients was launching a COVID-19 vaccine after an unprecedented development period. They needed a partner to support a massive, fast-paced global roll-out across more than 40 countries. Coordinating our expertise across Ashfield Engage, we quickly created a package of commercial and scientific engagement services. This included organizing more than a dozen virtual educational seminars and symposia, creating supporting literature, hiring teams of medical science liaisons, running global customer contact centers handling 1,500 calls a day across 32 languages, and providing a comprehensive medical communications program for a range of audiences."

So, quite a mountain of work as you an see....

Wise words Wigster.

Thanks Brand. On point.

This isn't recent news though Titania? I read the report last year - their loss at that point did not stop them getting pretty favorable terms on extending a bank loan, which i read at the time as their lender viewing their exposures as not hugely alarming, otherwise they wouldn't have financed on decent terms. You can find it somewhere in the guts of the report. The loss seems a lot but you have to remember that Synairgen were one of many many Biotechs that had their valuations slashed - the war in Ukraine also escalated, worldwide inflation went North, etc etc.... My point being that yes they had big exposure, but in context, it isn't really a thing of note, is it?

"We all thought we were perfect for STRIVE but there is nothing to suggest we are being considered as a possible candidate."

Mani as you are well aware, you don't speak for everyone when you make that statement. "We All" was never correct; "Some of Us" perhaps. No one here represents all shareholders. I know a large contingent of PI's that Never expected Strive to be on our path, but who remained cautiously optimistic, at best. They heeded the company's statements - that they were not uniquely focussed on platform trials and were indeed pursuing multiple routes. There is a lesson in there, if you care to learn it.