Member Info for Elegance

If the FDA had taken a pause pre covid vaccine then the brakes are off now, look how many applications are currently being approved seperate from COVID compared to last month https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

Eva you selling?

Looks like the FDA are working hard.

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

Leas

"there is always a possibility that Avion buyout IMM as the trial progresses"... Now there's a thought.

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page

Envisage..

Nolupus, I have seen you write that before and question why you write three years? I appreciate that it might take 3 - 6 months to get the study underway, I thought though that the last study lasted only 46 weeks, lets say another 3 months to understand the date works out to be perhaps 18months with news flow along the way? Why do you invisage 3 years? Where am I going wrong? Genuie question not taking the mickey.

8th october 2020 FDA website:

“Now, more than ever, we see the important role of these FDA grants to support clinical trials of potentially life-changing treatments for patients with rare diseases,” said FDA Commissioner Stephen M. Hahn, M.D. “As interest in the program has grown, so has the hope for promising approved therapies for patients with rare diseases that currently have no treatment options. These important clinical trials are at a critical time where additional resources are needed to support rare disease research during the COVID-19 pandemic.”

This year, as there are new challenges and increased costs for clinical trials due to the COVID-19 pandemic, the FDA remains committed to supporting rare disease research by providing existing grantees with additional funding. These new resources allow ongoing studies to implement necessary steps to allow their research to continue and assure the safety of study participants, to maintain compliance with good clinical practice, and to minimize risks to trial integrity.

https://www.fda.gov/news-events/press-announcements/fda-awards-six-grants-fund-new-clinical-trials-advance-development-medical-products-treatment-rare

Lambo... You cant have it negatoive both ways by saying its delayed until Q1 2021 or if its not now then there is a problem. It could very well be that Covid has delayed the SPA until tomorrow or next week for that matter, no knows, stop trying to be so negative and drive the price down to 9p when the placing was 11p. Have you got a short on or something? Cor... if the RNS does come out this week and someone does have a short on then they will be shirtless.

Lambo "that was a different department" lol... I thought you said FDA were only dealing with Covid ... FDA will be looking at all applications and approvals whilst focusing on Covid.

Been at least 67 days now since FDA SPA was filed (RNS is 67 days so could have been prior), 22 days over antispated due date. Surely we cant be waiting much longer now?

Leas, fair comment, I just wonder how much longer we are expected to wiat without news? I know its how long is a piece of string as Covid takes priority at the moment but like wise the world continues in the face of Covid.

£6000 sale this morning over two trades drops the share price 4%... that puts a total value on IMM at £150,000 Market Makers are scandolous...

Wonder how much pressure is being applied to the FDA at the moment?

This should be seen as good news, it shows that the FDA have the delay and not IMM or Avion, it further points out that the RNS can land at any point, those wanting to trade the share could be caught out at any moment, definately a share to stay in IMO.

MM's looking for sellers but want above 16p if you wanna buy, they know what's coming. RNS inbound.

8:46 am last buy was at 13.85p, next trade for 71173 shares at 14p an increase of 0.15p but when its time to sell at 12:13pm for the same amount of shares (71173) then it drops nearly a penny from the previous change. MM manipulation?

chesee I knew someone was going to say that, im in.

eva, how much is the european or even the eastern market worth? By the looks of it Immupharma have retained these areas and once they have fda approval they could market this seperately at a much higher value? I can't see how this is not a win win, avion are literally paying to get lupuzor developed which enables Immupharma to sell the licence to the european, eastern markets at a higher rate. thats gotta be worth a boom for a friday afternoon...

Yet the price waivers up and down to accomidate automatic trades at the lowest level?

Time for this to shift up a bit surely?

Is there any way to find out past history in terms of time scale for SPA approval from the FDA? For example, how long did it take IMM to get previous FDA SPA approval, I have checked all the RNS's but it doesnt appear to be detailed? Be great if we could see that they dont normally need the full 45 days and it likely within lets say 30 days.. thoughts anyone? Do we know how long it took last time? Appreciate we are with a heavy weight (Avion) that might assist with timescales.