Member Info for dallo

Nolupus
No mention but not surprising .
If the FDA gives go ahead on SPA I suspect we will hear something .
They don't seem to announce deals like Aspen until they are done...it is a private Group so no requirement to disclose anything unlike a public company.
A rejection by the FDA has no effect on their operations but a positive approval will be announced jointly by IMMU and Avion.
If you have no share price to worry why bother.

Avion Pharma and Aspen Pharma entered into a licencing and commercial agreement to relaunch Cenestin a drug to alleviate menopausal symptoms.
I dare not comment on whether any poster here would require such a drug!

Acella Pharma, Avion's sister company , also based in Apharetta has received a number of FDA approvals for generic drugs for Epilepsy, Respiratory ,Tyroid and other diseases.
It has an R&D department in the Alpharetta facility.
Anyone who has lived in the US like me know that the FDA approves many drugs that we in Europe /UK may not be comfortable using but the Americans want drugs for every minor ailment and this is reflected in the millions of dollars spent on advertising drugs on TV et al that nobody here has ever heard of.
That's why I feel the FDA will have no issues in granting a SPA to Avion Pharma...it really doesn't matter to the FDA until it has to approve the drug.

Balcotra the Avion oral contraceptive approved by FDA in 2018
There is much information on Avion's other FDA applications if you dig deeper.
DYOR

There is a wealth of information on Avion's drugs and therapies on its website including Gloperba it's FDA approved gout drug ( Jan 2019) and Cenestin plus many more.
It is all there including its joint ventures and it's relationship with major laboratories.
It is in plain sight...go to FDA recently approved drug site regarding Avion for another interesting product approval.

With the utmost respect nobody on this board mentioned Alora Pharma as being Avion Pharma and Acella Pharma parent company until I posted it yesterday or that the companies operate and are headquartered in a new 60000 sq ft manufacturing facility in Alpharetta near Atlanta , Georgia.

If you zoom in you will see the names of Acella and Avion outside this large facility.

I have Google the facility and it is very impressive with a lot of expensive cars outside.
Check out 1880 McFarland Parkway, Alpharetta , Georgia on Google

Alora Pharma moved it's Corporate HQ to its new 58000 sq ft manufacturing facility at 1880 McFarland Parkway, Alparetta, Georgia in 2018.

John
What about the the 60000 sq ft manufacturing facility.
Interesting

Alora Pharma has another subsidiary Acella Pharma which built a new 60000 sq ft manufacturing facility in Georgia 2 years ago to develop a range of products in the dermatology area.
It looks like these guys are kosher alright

John
Parent company Is Alora Pharma LLC based in Georgia and seems to be another Delaware incorporated company with probably a number of Pharma investors behind it.
FDA has to be assured of financial strenght of companies because of the Insurance cover required for engaging in drug trials in the US.
As long as they are kosher we will take the $25m
which is substantially higher than Immu could muster for the last shoestring Phase 3 trial.

John
That is why I said that Avion's meeting with the FDA is the most important of all for this obscure Pharma from Georgia ,USA.
If Avion doesnt cut the mustard with the FDA it will be a short meeting
However they must be kosher otherwise the FDA would not let them in the door.

John
I have found that it pays to be cautious when it comes to Immupharma.
I cannot imagine what the management of Avion are feeling as they approach
perhaps the most important moment of their careers with the FDA meeting in just under 2 weeks
time.

By the way if the Phase 3 is a success the BIG WINNER will be Avion who could be transformed into a near $billion company all on the back of a $25m punt.

Nolupus
I accept your points most of which are valid .
However rather than obsess over dilution and the number of shares currently in issue we should focus on the market cap.
You will remember like I do the comments made by our Chairman Tim prior to the results of the last Phase 3 trial and after raising funds at 144p where he stated that the then market cap of Immu of £300m was not much for a company with a " $ billion" drug ( Lupuzor).
The current market cap is c£30m and if we were to progress ( following successful SPA approval from the FDA) to a better funded and highly structured Phase 3 with Avion spending up to $25m then it would not be inconceivable that Immu could not reach a market cap of $60m or more during the trial in anticipation of a successful outcome.
A successful outcome could see a market cap of c£250m based on Lupuzor achieving a 10/15% of the Lupus drugs market.
Avion would capture the US market with 1.5m Lupus sufferers ( 30% of the world's total but more than 50% of possible revenues) leaving Immu to do deals for the 3.5m Rest of the World market .
Assuming they do similar deals (or better) to Avion with other Pharmas then we can see how a market cap is more than possible.
10% of total market of $3b is $300m.
Assume Immu get say 15% royalties (17% with Avion) then possible Immu annual revenues could reach $45 m.
Throw in up front one off payments ( see Avion deal) and add value of UreKa Sarl and Incanthera stake you get an idea of what the market cap could be IN THE EVENT OF A SUCCESSFUL PHASE 3.
All pure conjecture on my part and a very long way to go so still highly speculative and investors should be very cautious.
Lessons have been learnt and we will not be any where near a £300m market cap going into the next Phase 3( if it happens) like in in the last feeding frenzy in 2017.
Above figures are pure conjecture on my part and investors.....DYOR
First we MUST get SPA finalised and that the games can begin.

UreKa Sarl not Ereka Sarl.
Apologies...time for the cocoa!

Nolupus
30p on SPA may be a stretch I agree but the Lupus drug market annual sales is expected to double from the 2017 $1.5b to $3b by 2024 .
Immu is funded from now until 2023 and hopefully no more dilution.
The Pharma sector is being priced on higher multiples than in 2017 and so I have nudged the SP post successful SPA approval to nearer 30P based on potentially higher revenues for Lupuzor IF PHASE 3 IS A SUCCESS.
Also other assets such as Ereka Sarl and the Incanthera stake may surprise on the upside
May settle back from 30p to 20/25p once gamblers leave and then the wait will begin for the very patient.
Just my thoughts and I have been wrong many times so DYOR.

Eva
Over 5m people worldwide suffer from Systemic Lupus with over 1.5 million alone in the US and the market for Lupus drug therapies is expected to grow to $3billion in the next 3 years as sadly more people are developing this autoimmune disease in line with other diseases like Diabetes etc.
Lifestyle and genetics are playing a part in this rise and Lupuzor could have a role in treating many more autoimmune diseases thanks to the groundbreaking work of our own Dr Muller who is on Macron Covid team in France.
If Lupuzor was successful as a treatment in conjuction with steroids ,antibiotics and antimalarial drugs it could be much more than a Lupus therapy but have an effect on many more autoimmune diseases.
But first the SPA from the FDA!

I forgot to mention that Glaxo has an approved Llupus drug Benlysta which was approved in 2011 and combined with antibiotics and anti malaria drugs is the current standard treatment for Lupus sufferers but has significant side effects.
All the major Pharmas have Lupus drugs in trials but none as far as I am aware are advanced as Phase 3 candidates.
I stand to be corrected on this point but Pfizer are currently identifying Lupus patients who are Antibody Positive for future testing.