Member Info for dallo

Cuvio
Exactly
If the FDA flatly refused a further Phase 3 for Lupuzor then we would have had to be informed immediately via RNS.
So it is all about the guidance given and requirements/ protocols sought by the FDA in its written response.
These require detailed review and analysis by Avion and its advisers before we get the final decision via RNS.
Fingers crossed.

Curious
The FDA has responded but it is still unclear what the suggested protocols for the trial are.
If Avion ,who are paying $25m for the pleasure ,find the FDA protocol conditions acceptable it will move ahead.
If they are too onerous for Avion, then they may have a rethink....however another larger Pharma may not find the FDA stipulations too difficult and step into the breach...unlikely obviously as I don't think Avion will walk away unless the FDA is putting insurmountable obstacles in its path.
I do not think this is the case but hey this is Immupharma where dreams and reality often collide.
Imho

Nota
Again we don't know enough on what is in the FDA written response other than it is detailed but all FDA written responses on drug trials are detailed.
Nearly 20m shares traded so far today but large scale selling appears to have abated .
Will buyers pile in on a more considered view of the RNS ?.
We are about to find out.
ATB

Interpretation of wording is important..
What does the wording mean .."the FDA gave significant guidance on the protocol which could be AMENDED to IMPROVE regulatory outcome".
If you are an optimist you might say that the FDA is making positive suggestions to insure that Lupuzor passes the Phase 3 trial and if you are a pessimist that the FDA is putting stricter conditions on the testing protocols.
We shall soon find.
If we get a bounce today it may be significant imho
ATB

This morning's RNS and the wording contained therein was approved by the company and its NOMAD, SPARK Advisory partners and as such had to be deliberately circumspect as the discussions with Avion on the detail of the written response have still to be held.
If the written response contained serious negative comments by the FDA or even its refusal to allow a Phase 3 trial then this information MUST be given to the market IMMEDIATELY as it constitutes significant insider information under the Market Abuse Regulations which could have severe consequences for both the NOMAD and the company if not disclosed.
Hence I feel the company could not use words like " we are delighted " etc until discussions with Avion are concluded.
If the FDA signalled that the process was dead in the water unless major changes to the protocols then I think the NOMAD must insist on this being disclosed immediately.
So it is now down to Avion to proceed or not but that was always the case.
Imho

I repeat that they had to rush out the release on receipt of the written response from the FDA under the Market Abuse Regulation as the receipt of the response constituted Inside Information and must as soon as practical be released to the market.
So the FDA written response was received , I suspect, yesterday and after a brief review the RNS was issued this morning to abide by the Market Abuse rules.
I expect a more considered and positive RNS to follow very soon.
Imho.

I suspect if Immupharma had put "is delighted" to announce.. the SP would be 12p now.
The written response was possibly received in the last day or so and Immupharma issued a confirmation of this today to avoid possible market abuse.
Obviously it cannot say it is delighted with the FDA written response until it is discussed in detail with Avion.
I thought the FDA response looked very proactive and encouraging and absolutely no suggestion of the FDA saying the Phase 3 cannot proceed.
In fact it now looks a certainty once protocols are agreed.
Very optimistic now despite markets knee jerk reaction which I think will change on mature reflection.
IMHO

Lord
That's a bit silly
The FDA will opine very soon and if it is positive then Immupharma is absolutely fine.
If it is negative then Avion will not have any further involvement in Lupuzor or Immupharma.
Immupharma will tank and Avion will move on with no real financial cost other than its ( Alora) investment of c£1,1m in the placing.
There will be no waiting around and the herd will move on imho.

DJm
If the FDA approves the Phase 3 it will be based on agreed protocols involving trial structure, number of trial patients, Lupuzor tests v placebo ratios, target cohort with antibody positive markers, geographical/ racial dispersion, agreement on a fully recognised and experienced drug trial company conducting the work and detailed endpoints to be reached among other requirements clearly set out in the FDA written response.
It may take some days for Avion and Immupharma to evaluate the terms and conditions of the FDA requirements so this could explain the delay.
It is a very serious financial commitment by Alora/ Avion so they have to make sure all the ducks are in a row and are confident they can succeed in getting Lupuzor through the Phase 3 and on to commercial delivery.
No business is going to commit to such a large financial outlay without full deliberation on the prospects of success.
Still all to play for imho.

Lord
As a professional you must chose your words carefully but he did say categorically on the webcast a few weeks ago that they could have proceeded to Phase 3 last year but wanted to do everything by the book in collaboration with the FDA.
He implied that the FDA decision was purely a rubber stamp event.
We shall see.

The FDA is 2 weeks late with its written response to Avion on the Phase 3 Lupuzor go ahead so it is natural for some investors to get jittery and take some chips off the table particularly those who got in before the expected agreed FDA decision date via spread bets and T10/ T20s .
Immupharma has a history of false dawns and only the brave with strong nerves ( like me) could manage to stubbornly stay the course for , in my case, 8 years.
McCarthy is adamant that Phase 3 is going ahead but he has a credibility issue imho.
I hope for all LTHs we get positive news soon because we deserve it but in life sometimes you don't get what you think you deserve.
Fingers crossed

Frits
The best laid plans of mice and men often go awry
Robert Burns
Our fate now await us in this critical week ahead.
Duck or no dinner
ATB

Maid
You could be right but they were shown as sells
at the then bid price.
Trades all over the place today...hopefully we will be put out of our misery tomorrow.

Still sellers around
C230,000 just sold at c6.4p
Doesn't appear to be any leaks as yet from the US
so FDA continues to dawdle along at a leisurely pace.
Nerve shredding wait continues nearly 2 weeks after deadline date.
Some short term punters and spread betters closing positions imho.
ATB

In the end of the day the options were paid for and Immupharma received the cash.
Ok the option price was 5p not the current c6.25p
market price but that was the deal made at a time when it looked like the company was going bust .
Like the rest of us L1 could lose all its money if the FDA says no .

Volumes now gone through 4 million with good 2 way trading taking place as possibly the bewitching hour of 2.30 pm ( 8.30 US ) approaches.
If the news is good then expect " friends " of Alora/ Avion in the US to maybe get a slice of the Lupuzor action via investing in Immupharma.
Squeaky bottom time

Trades all over the place...MMs struggling with sudden volume surge....3m shares dealt so far.
Smells of news from the US at start of business there.
Interesting indeed

Maybe false alarm by me
300,000 gone at 6.36p.

Momentum building here with 300,000 bid at 6.36p and just 25,000 on the offer at 6.4p
Looks like we could go higher soon.
I wonder is the news out in the US and Avion now reviewing the FDA written response...a week overdue so a possibility imho.

Lambo
Labor Day today in the US so no news on the holiday.
Maybe tomorrow or sometime this week ...who knows.