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Then you’re forecasting bankruptcy.
Bright Boy are you serious ?
Yes if there`s organic upward momentum then a r/s is fine but if its in a bid to stay alive , then its simply the end.
The study I did (all US quoted biotechs with m/c 750-1.025bn over last 5 years that have reverse split ) saw 22 such companies demise to zero .
One thing I`m totally convinced of is whatever the outcome it will be sorted within a matter of weeks from Top Line release day , with the binary outcomes being obvious buy out vs obvious bankruptcy.
Good god no , if we did that , its would strongly suggest , in the words of Johnny Mathis and Denise Williams. ` Yes, its over `
Reverse Split Study .
Right: See below 31 companies that have r/s in the last 5 years with a market cap between $750m- $1.25bn
Top left are the oldest charts and r/s 5 years ago etc ..
Of course there were a whole load that went to zero but if our data is good but not ` that good` it would seem a r/s isn't quite a friggin terrible as it sounds.
So :
Good to very good data DO NOT r/s,
`OK` Data maybe r/s
Sketchy debatable data ,its over so none of it will matter.
Breakingviews -
MRNA is a $120 billion bet on platform, not vaccines
By Robert Cyran
3 MIN READ
A researcher works inside a laboratory of Chulalongkorn University during the development of an mRNA type vaccine candidate for the coronavirus disease (COVID-19) in Bangkok, Thailand, May 25, 2020. REUTERS/Athit Perawongmetha
NEW YORK (Reuters Breakingviews) - Biotech firms Moderna and BioNTech used a biotechnology known as messenger RNA, or mRNA, to produce vaccines effective against Covid-19 with miraculous speed. That has pushed the combined worth of specialists in this emerging field to more than $120 billion. That’s a glimpse of what’s possible if it can be applied post-pandemic to treat cancer or rare diseases.
The technology is the closest thing yet to making medicine digital. MRNA vaccines essentially inject genetic code that instructs a recipients’ cells to construct a part of the virus. The body recognizes the produced protein as foreign and mounts a future immune response when exposed. Moderna and BioNTech’s vaccines show the technology works fast. Vaccines typically take a decade to develop. They took less than a year.
The total annual market for vaccinations is about $35 billion, according to Bernstein, and dominated by firms like Pfizer and Merck. Big pharma companies are valued at 5 times revenue. Put mRNA firms on the same multiple and that implies investors believe they will capture about two-thirds of the market.
It’s possible. The speed of mRNA therapeutics is a big advantage. For example, flu vaccines only reduce the risk of illness by up to 60% because makers must guess which strains will be prevalent each season. Sometimes they’re wrong. Shaving months off means better guesses, and higher efficacy.
The bigger opportunity comes from the validation of the mRNA “platform”. Instructing cells to produce desired proteins could lead to multiple advances. Perhaps they can instruct the body to more vigorously attack cancerous cells or repair damaged tissue. Producing missing proteins might fight inherited diseases.
It’s not a given. The body breaks mRNA down quickly, and larger doses trigger immune reactions. That can be a benefit for a vaccine, or possibly treating cancer, but it’s a problem for other uses. Researchers have figured out some tweaks – a layer of fat around mRNA vaccines keeps them circulating longer – but they’ll need more.
Success against Covid-19 means these companies will be flush with cash from sales and attract partnerships and scientific talent. That should make 2021 a watershed. There’s a hopeful precedent in monoclonal antibodies therapy. Sales only took off about two decades ago, but should reach $150 billion in 2020, estimates EvaluatePharma. That’s worth perhaps $750 billion based on a multiple of five – and gives a view of what might be possible with mRNA.
UK to fast-track drug trials to boost post-Brexit life sciences
Companies will need to apply separately to register new medicines when Britain leaves EMA
Britain was the first country in the world to approve the Pfizer/BioNTech Covid-19 vaccine © AFP via Getty Images
Sarah Neville in London YESTERDAY
32
Print this page
Drugmakers will be offered fast-tracked approvals for innovative medicines in the UK as ministers seek to build on the country’s world-leading approval of a Covid vaccine and attract life sciences companies to invest post-Brexit.
The UK’s medicines regulator will become independent of EU pharmaceutical rulemaking when Britain quits the European Medicines Agency at the end of the year, which means companies will need to apply separately to register drugs.
With ministers eager to try to refashion the UK as a post-Brexit hub for global life sciences, companies with drugs that promise to treat unmet medical needs will be offered help through the development process, including manufacturing, according to three people familiar with the situation.
Under the so-called Innovative Licensing and Access Pathway, companies are set to be offered the same rolling review of data that speeded approval of the Pfizer/BioNTech Covid-19 vaccine ahead of the rest of the world.
The move will also try to counter the threat that pharmaceutical companies will push Britain to the back of the queue for drugs given it accounts for just 3 per cent of global pharma sales.
Officials and some National Health Service staff fear that new medicines will be delayed in the UK if companies are discouraged by the extra bureaucracy from seeking approval from the UK regulator, the Medicines and Healthcare products Regulatory Agency.
One person familiar with the plans said that “life sciences can be one of the things at the centre of the UK’s post-Brexit policies”.
The UK is still locked in eleventh hour talks with the European Commission over a trade deal, with disagreements remaining over fisheries and the fair competition level playing field.
The person added: “[Ministers] want [the UK] to be seen as a place where people come to develop innovative medicines. That’s why they were over the moon about the Covid vaccine being the first [to be approved] in the world.”
However, one industry figure, who spoke on condition of anonymity, was sceptical that a company would tailor its trials and data generation to the demands of the British market.
“A company is not going to do data just for NICE [National Institute for Health and Care Excellence] when the UK is a fraction of global pharma sales; it’s not going to spend millions on studies just for the UK,” they added.
The executive argued that a far bigger overhaul was needed of the framework that NICE uses to calculate value-for-money. A review of the agency’s methodology is under way and any changes are expected to be announced in the spring.
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ExplainerCoronavirus treatment
How UK approved BioNTech/Pfizer vaccine ahead of EU
Britain has long been criticised by the pharma industry for the slow rate at which the NHS adopts new medicines.
An analysis commissioned by Pfizer in 2017 identified Britain as a laggard in the speed at which patients received new treatments, with a 75 per cent lower uptake of new drugs in their first year of release compared to France, Germany, Japan, Switzerland and the US.
Later that year, the UK’s life sciences industrial strategy set a goal that Britain “should be in the top quartile of comparator countries, both for the speed of adoption and the overall uptake of innovative, cost-effective products, to the benefit of all UK patients by the end of 2023”.
Under the new plan, the NICE and its Scottish equivalent, the Scottish Medicines Consortium — the bodies which determine whether a treatment offers value for money — would be “in the room” from early in the development process.
Companies would be given immediate feedback on what a drug trial would need to demonstrate, and what data it would need to generate, to have the best chance of receiving a positive assessment. Patients’ views and priorities will also be integrated into the development process.
Hope so , thanks
OK thanks I obviously was thinking the Lancet would have a greater UK readership and relevance
and aligned with what goes on here rather than there . thank again
JJ , the Lancet is a UK publication so if we meet the new endpoints that are directly relevant for consequent UK approval and thereafter use by UK physicians I can’t imagine the Lancet would take some moral high ground in effect saying they think the MHRA were wrong to change the endpoints and not want to publish what would be a very high profile piece of PR for them ?
What am I missing please ?
Jack i’ve asked that nearly everyday - we’d open at $3 the next session if they did .
Flip , something i’m very unclear on is we know there was one SAP ( revised ). LP stated she would not DL till she had buy-in from all 4 regulators . We know for sure we have had buy-in from two of those and that alone guarantees a degree of success and as I said earlier. that’s got $5 day one on TLD written all over it .
So what if she never got buyin from the FDA and Canada would she have never locked the data because that’s what she very clearly said in the public domain , and then what ......?
I think the FDA didn’t respond and that’s supported by the fact NWBO have not updated clinicaltrial.gov and i’m suggesting that LP said lock and start the analysis anyway because what she said re all 4 buyins before locking
is simply and utterly ridiculous , or am I missing something ??
Then come TLD day , of course we can say ‘ met endpoints 1 ,2 ,3. etc etc ‘ because we did in the UK and EU
and then what , another PR. saying we failed US endpoints ?
Also you said to me earlier that no response from FDA could be tacit approval as such , but at what stage will the company know ? I believed from first hand information that we have had a long term good relationship with the FDA and of course its not in the FDA’s interest or those they serve to be obstinate .
I’d really appreciate your insight on the above as i’m honestly confused about these points
Thanks
(Of course update FDA site and we open at $3 same day and all is forgiven ...)
Hope you’re right but even if youre not we trade $5 day 1 on EEA and U.K.
Ok poor choice of wording on my part , Try FDA did not respond to our revised SAP
and whilst LP was adamant of no DL without ‘ buy in ‘ by all 4 regs , it wouldnt be the first time
she said one thing and did another
Here it is , you read it here first ,
1. No FDA website update as the FDA did not agree the new SAP endpoints. ( BTW. what happened to Canada i’d have thought they’d have been more aligned with EEA & UK )
2. Top Line Data endpoints PR will indeed and correctly say ‘ met endpoints ‘ but once the dust settles
it will be clear the trial has met EEA & UK endpoints meaning the FDA will effectively banish GBM patients from your 52 states and send them as health tourists to Europe.
3. The warrant lock up extension has been canned as our executive management have been de facto caught with their hands in the cookie jar , but to be honest if we get TLD that meets primary endpoints I for one don’t care , Ive known they were self serving for a long time
4 Innes has exposed himself as thoroughly untrustworthyIi believe he said to all and sundry something along the lines ‘ do you really think we are stupid enough to allow warrants to be exercised with in a few days of TLD ‘.
5. The companies offer to warrant holders to extend post TLD is pathetic and serves no purpose other than expose the companies lack of conviction that a higher share price can be sustained , Whilst I don’t think that is the case , I’m simply saying that’s what is implied by their ridiculous offer and that they’re too stupid to realise that as they think nothing through , literally nothing ...
...so No and Yes ....
You said no evidence for illegal shorts which is correct because there aren’t any but
i’m afraid what you use as evidence for market makers ‘maximising profits ‘ is anecdotal at best .
You might want to look at how market regulatory governance added to the digital age we live in have changed
all of these practices for good . You could start with the Volcker Rule , Dodd Franks , Mifid 2 & 3 and Mifir by which time you may well have lost the will to live , or you might just believe me.
Anyway thanks for your thoughts .
VuBru , Ive got a question for you , in fact two :
Do you think there are illegal shorts of NWBO ? &
Do you think market makers try to suppress our share price , ‘walk it down’ etc etc ?
Just a yes or no to each would be great .
Many thanks
Exactly , that’s why I asked Senti , have they drip fed that to her , because the only
reason they’d ever do that would be lack of conviction we could maintain $4+
Soj , the market will buy our stock when we give it reason to buy our stock.
Currently we are in no mans land , no 10q , no update on TLD other than anecdotal , also sorts of b/s around warrants, NO UPDATE OF THE FDA ENDPOINTS and in biotech world especially on the Walt Disney OTCBB exchange that means a flat day to small down is actually a good day.
Senti - that’s the first time i’ve noticed you refer to the possibility of a reverse split .
If you’ve been drip fed that possibility by the company then I find that incredibly worrying because
we got to $2.50 with just one buyer in October and yet the company may be contemplating
the possibility of not being able to sustain $4+ post TLD and ‘major ‘ publication.
So can I ask you straight has the possibility of a reverse split been said to you, even in passing recently
by Les Goldman or David Innes ??
Good to hear - thanks Nikolay
This is what I posted recently re timeline :
TIMELINE
I saw Senti`s possible timeline and I certainly hope she`s right.
I was thinking along the lines :
1. Data lock announcement 5th October
2. Company know that they met endpoints at very latest 19th October
3. Between 1st & 15th November conversations instigated with the major
medical journals interested with an exclusive on the Data Set and final decision made on which one to go with.
30th November article written and presented by LL or Marnix for fast track to said journal (someone posted The Lancet turn these submissions around in about a week and publish weekly ) So maybe there`s some back and forwards on that article but time line wise , theres no reason why it isn't ready to go
In the mean time we have seen Poignant recruited for up-listing to NYSE
and we`ve heard Les G running around trying to get the lock up period on warrants extended.
Merck, Eisai Say Keytruda Study Met Primary, Secondary Endpoints in Patients With Advanced Endometrial Cancer
(MT Newswires)
Merck & Co. (MRK), in partnership with Eisai, said Wednesday its phase 3 study of Keytruda in combination with Lenvima met the primary and secondary efficacy endpoints in patients with advanced endometrial cancer.
Based on the results, the combination therapy demonstrated a statistically significant and clinically meaningful improvement in overall survival, progression-free survival and overall response rate. The safety profile of the combination therapy was also consistent with previously reported studies.
Merck and Eisai intend to submit marketing authorization applications based on these results, according to a statement. Price: 80.99, Change: +0.51, Percent
Agreed ` family offices ` as they don't hold client money and therefore are not restricted from buying on OTCBB
`donations paused `
actually I think it means he knows none of us will be ultimately disappointed
I find Dave Innes's level of arrogance actually reassuring..
Simply marvellous.
Flip - Yes I remember the RSC Actor , and the chill of finding out he'd died . If I remember correctly his agent posted something on social media about his passing ....very sad
It is unthinkable that the company did not know if they`d met end points and were stat sig within 14 days of data lock.
TIMELINE
I saw Senti`s possible timeline and I certainly hope she`s right.
I was thinking along the lines :
1. Data lock announcement 5th October
2. Company know that they met endpoints at very latest 19th October
3. Between 1st & 15th November conversations instigated with the major
medical journals interested with an exclusive on the Data Set and final decision made on which one to go with.
30th November article written and presented by LL or Marnix for fast track to said journal (someone posted The Lancet turn these submissions around in about a week and publish weekly ) So maybe there`s some back and forwards on that article but time line wise , theres no reason why it isn't ready to go
In the mean time we have seen Poignant recruited for up-listing to NYSE
and we`ve heard Les G running around trying to get the lock up period on warrants extended.
I believe GBM. But I can’t look it depresses me !
And remember this year will be the first year they actually even break even.
actually I`ve been there for dinner but not stayed, I normally stay at La Mamounia .. At $30pps I will arrive by PJ and have rose petals scattered for the whole of the 10km journey to the hotel ! :)
So you don`t think they are unblinded ?
$485m revenue in 2020 projected $580m in 2021 thats why ...
Thing is Flip, then its Xmas , then its New Year , then its Orthodox Xmas, then its snow storms ...
Long Only`s such as The Capital Group make a big deal of the fact they do not do `timing` they make a decisions and they buy or sell accordingly.
We should do the same , the market cap will be the market cap at buyout indifferent of what the daily PPS is doing .