Member Info for FatherTedCrilly

Apologies if already posted (I'm not on the boards so much these days...)

Pfizer announces priority FDA review of there RSV vaccine candidate:
https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-biologics-license-0

Hvivo Challenge trial of the Pfizer's vaccine candidate, last year :
https://clinicaltrials.gov/ct2/show/NCT04785612?term=hvivo&draw=2&rank=9

Nature magazine covering the story (sadly no 'name-check' for Hvivo - but industry will be aware)
https://www.nature.com/articles/d41586-022-04434-5?utm_source=Nature+Briefing&utm_campaign=c197f8e3d9-briefing-dy-20221216&utm_medium=email&utm_term=0_c9dfd39373-c197f8e3d9-46467506

I continue to feel this company is significantly undervalued, considering what they do and who their clients are.
I hope everyone is having a good weekend :-)

"This could be the exact opposite."
One month of informing shareholders what is actually going on?

"around 95% of applications eventually pass this stage"
Is that 95% of all applications? Or 95% of applications that have been refused because the " MHRA has indicated that it seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority"

1 calendar month tomorrow since the CTA was rejected (and sorry, but in the absence of any explanation - I'm going to say 'Rejected').
Anyone here (except Afham) still think this is an administration issue? One month. One month and utter silence.

I've no problem with people who take a different view on vaccines from me - but this is a share BB.
Take it somewhere else guys... or don't - I can't see your posts anymore, so I don't care.

"Realistically no surprise though, leaving the update to the very last moment possible meant we all knew what was comming"
Pretty much this. Disappointing but not surprising. Hopefully it will have been partially factored in...

Nice :-)
Thanks for posting

From the actual RNS.
"Sareum and its advisors are seeking additional clarification from the MHRA and will provide an update on next steps for resubmission as soon as possible."

Resubmission may, or may not, be in the pipeline. We simply don't know...
Sareum 'might' know - but so far they haven't shared that information.

Ahfam, how long without news on the CTA before you start to feel uncomfortable?

There is no conflict between HVO and POLB - it is a good use of assets.

The two main reasons given for spinning out POLB-001 were:
1. Hvivo is not a drug development company - and Hvivo's money should not be spent on drug development
2. Developing assets that would potentially be in competition with Hvivo's clients is not good for business (e.g. influenza drugs / prothylactics)
I'm paraphrasing - but that is my recollection.

The second point, about not being in competition with Hvivo's clients, can equally apply to the data - and identifying new drug candidates... which is why I believe the data was given to Poolbeg. It is a separate company - so this removes a potential conflict of interest.

Whether or not Disease in Motion (DiM) has been put on the back-burner to allow Poolbeg to get a jump start on the data... as there 'may' be more value in developing drug candidates than selling the datat? Well, that would be speculation - but I know what I think :-)

It isn't just bashers though, is it?
Long term holders are getting frustrated at delays and lack of progress... and annoyed at the lack of communication / respect towards PIs.
In the absence of good positive news (or at the very least, more detail on the CTA) the AGM could be quite spikey. And deservedly so.

You appeared to be suggesting a capacity problem was the reason for contracts starting a year in advance, when in reality it is the time needed for trial design. Future contracts are good news, not a problem.

Scriv - HVO do a lot of phase 2 studies... these drugs are ready. I think you know this though...

I don't see capacity as an issue, the timing of trials will be part of contract negotiations. Also, as CF demonstrated, establishing new capacity isn't an issue if needed.
Other than general market (and sector) conditions the big change has been HVO's perception as a Covid / non-Covid stock. When the Covid challenge trials were being sought by the UK Government , PI interest was huge. Now the perception is just a 'humble CRO', we don't attract the same kind of investors.
What I see now, is an under-valued stock that could easily be 2 or 3 times the current SP. It might not have the 8x or 10x potential it once did but it is also much safer, with a great cash balance, order book and pipeline.

ColSoul
"A director of a fully listed company is obliged to notify their company of any dealing in its shares within four business days, and the company must pass that information to the market by the end of the following business day. "
Suggestion's that CF is selling shares is simply wrong - the market would have to be informed. However, a previous employee of the company could be (just IMHO).
There is certainly a new buyer (Allan Rankin) and he could be adding for a while without triggering another TR1...
Have a great weekend all

Hi JCblue29

Given that there was no reason for the drop in share price (other than general market conditions, war in Ukraine etc.) and that Poolbeg have delivered on every target they set themselves, you could see the recent increase as a natural correction...

Also, to add to Cashintime's excellent post, the recent artificial intelligence RNS has highlighted Poolbeg's 'unique' dataset. No one else in the world has this data. The potential to discover new drug targets and, eventually, new treatments gives the the company huge potential IMHO.
(and obviously, this is just potential at this stage)

Have a great weekend all - I'm switching off from shares and switching on to Rugby :-)

If they only wanted more info from Sareum then why state "a review by the UK Good Laboratory Practice (GLP) Monitoring Authority"?

I suggest people read the RNS again, carefully.
Specifically this bit: "the MHRA has indicated that it seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority"
If indeed, this is an 'administrative' error as so many here are suggesting, then this is the most badly phrased (deliberately?) RNS I've seen in a long time.
The MHRA wants the Good Laboratory Practice Monitoring Authority to review Sareum's application. This doesn't sound like it is about a typo... this 'could' be calling into question the laboratory processes that produced the pre-clinical data.
Serious issue - or appalling RNS? Looking back on today I'm stunned at only 30% down.

Moni -agreed :-)
Though I'm hopeful this might kick-start some interest there too...

An alternative view is that some investors have decided to de-risk and sell some/all based on uncertainty, lack of clarity and consistently missed deadlines... and these are the prices they are prepared to sell/buy at.

JS on good form and obviously excited. He covered a lot of ground and, while not much new info for existing investors, his comments on the Artificial intelligence programs were more than worth the watch!
Multiple new drug targets have been found for RSV... and several times he stressed that 'no one else has this dataset' (referencing the clinical trials data provided by Hvivo).
He also called the dataset "Pristine". Now, I work in tech and I'm very aware of how valuable good data is - and what can be accomplished with the right interrogation. I'm now more excited about this than I am POLB001