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Madeit
When fda set a date they genuinely on time if they are not they let the company know beforehand. So 29th aug is dead on..
we are not 100% certain that the FDA decision RNS will land Tue
for balance, but anytime next week and i will be over the moon''
and for some reason, and looking at it logically i truly believe they will get approval through
second time of asking, because they would have learnt from the first,
what's to be expected..
good weekend
"ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to provide an update on the Lupuzor™ pharmacokinetic ("PK") study, as part of the new optimised international Phase 3 trial of Lupuzor™ in Lupus patients."
It’s the first time I have seen the FDA asking for a PK study to give the go ahead for a P3 clinical trial ..
The explanation is , imo again contained in the brief paragraph of the RNS …see below …Lupuzor update
As part of the regulatory process, the Investigational Medicinal Product Dossier ("IMPD") required significant revision, due to the inclusion of a new proprietary synthesis of P140, which consequently affords greater IP protection and lower cost of goods.
Last time they didnt ask for pk study to commence phase 3 but in the presentatiom they said it needs to be done before fda approval of drug.
Maestro ,
Why do you think the FDA asked for the PK which is usually a P1 trial ?
But
I agree wholeheartedly that even preclinical not to mind P2 assets are sometimes valued at 100’s of millions .
Welcome to the biotech world !
Company is calling lupuzor a late stage phase 3 drug, so dont know why fda will ask for phase 2.
Seen many phase 2 drugs valued alot higher in usa, in tune of over$100m.
Yes like a two horse race either number1 UP or runner number 2 DOWN the flags being waved and theyre off finishing line on Tuesday. Ha ha
Lambo222,
Thanks for taking a neutral and unbiased approcah regards how this will pan out next week. I fully agree with you, it will either go up or go down, depending on what the FDA decide.. Its refreshing to see that you dont have an alternative agenda and your posting are not of a passive aggressive nature.
It will be, what it will be..
Kind regards
Frits
Yep will most likely tank below 6p before close as people de risk
But would Avion find a phase 2 trial that’s the question, we will know by Tuesday if it’s good news, bad news and it will like let be a delayed rns as is usual for aim, GL all
Time for the bedwetters to leave the building im staying for the ride. Confident of positive FDA result
I would hate to be out of this over the weekend...
Sorry, could not help myself..
Frits..
Lambo222,
90% drop is not conceivable as the worst case scenario, IMO , is that the FDA demand a P2 trial but everyone to their own opinions .
Everyone should calculate the odds and be prepared for a major move .. Up or down
Whatever will be will be
we will either lose 90% on Tuesday or it gets bought up on positive news, it’s a gamble as ever, GL those who are taking the risk
Notaflipper
I agree with your analysis.
Just one amendment..Alora Pharma, the parent company of Avion and Acella, made the investment in Immupharma at 11p.
Alora is a major private Pharma based in Georgia,
USA and bought the legacy businesses and a manufacturing facility from Osmotica last Year for $110m cash plus $60m milestone payments.
The Alora group has a wide range of branded and generic drugs in its portfolio and is valued north of $1b.
It has extensive knowledge of working with the FDA over the years and has successfully obtained
FDA approval for a number of its drug therapies.
The involvement of the Alora group headed up by Art Deas is what gives me greater confidence in a positive outcome next Monday.
Fingers crossed ??
Mean while, 5 months later, The FDA did not even require a meeting, a written letter was suffice.....
July 7th 2022
https://www.lse.co.uk/rns/IMM/confirmed-fda-response-date-for-type-c-meeting-d8udk10m3ifedgo.html
As noted in previous announcements, the PK study required by the FDA met all the key endpoints and in-line with all human dosing to date, P140 was safe and well tolerated across all doses and in all subjects.
As reported from the previous phase 3 trial, patients who were biomarker positive (anti-ds DNA antibody positive) responded better to Lupuzor™ than those who were biomarker negative. However, in the previous study patients were not screened and selected on the basis of biomarker positivity prior to randomisation. The biomarker will act as a very useful "theragnostic" to ensure that Lupus patients who show this biomarker have the best opportunity to receive the maximum benefit from Lupuzor™ therapy.
The new international Phase 3 clinical trial protocol requires the presence of the biomarker before being allowed into the study. This protocol was accepted by the FDA at the previous Type C meeting in 2021.
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said: "We applaud the quick turnaround from the FDA in respect to Avion's request for this Type C Meeting and pleased to note the FDA's confirmation that only a written response is required and no face to face meeting is needed."
Relax and have a good weekend all.
Frits
The link is as follows …
https://www.lse.co.uk/rns/IMM/lupuzor-update-q1rdbjyj9nbs9kx.html
Lambo222,
As you seem too busy ( buying ? ) I will share the info ..
The paragraph from the RNS stated
As part of the regulatory process, the Investigational Medicinal Product Dossier ("IMPD") required significant revision, due to the inclusion of a new proprietary synthesis of P140, which consequently affords greater IP protection and lower cost of goods. The new IMPD was submitted to the MHRA and, following a full review, the MHRA has approved the commencement of the PK study.
Next , Lambo222 ?? :-)
Decided to buy back in as the risk and reward here seems to be better I thought before.
- Insiders have skin in the game this time;
- From the technical point it looks like it found the floor (triple bottom;
- US partner/managing agent with good track records with the FDA
all i know is there will be a rumble in the jungle when this gets going
for the weekend, for the expectation of a good result for next week
moving on up time to break free'' LOL!
GLA
Hi Lambo222,
Can you provide a link regards the change in the Drug & Formula.
Had a TV 175 May or maynot mean anyting to you...
Kind regards
Frits
I appreciate the motivations, however the binary nature of some of this commentary seems frequently to overlook that there has been some risk mitigation already to make this less of a binary decision. It is as if for example, the Lupuzor/P140 Pharmacokinetic ("PK") study passed in April 2022 had not happened. Nor that there has been some confidence building measures such as a the stake by Avion, nor that the FDA decision will be given in correspondence without the need for being face-to-face.
Also, the commentary here frequently seems to overlook why the original P3 trials failed. Similarly, that there was a recent previous Type C meeting in 2021 which already agreed that the new international Phase 3 clinical trial protocol would include the presence of the biomarker before being allowed into the P3 study. So, as this protocol has already been accepted by the FDA and the PK Study substantiated the human dosing; then the commentary of a binary "unknown and unknowable" decision being repeated ad nauseum by some recent past vocal supporters seems a bit disingenuous at times. I have to admit I have concerns over TM's performance, length till P3 results and share dilution as a result of funding requirements at arguably lower placings than needed. However, as my sp aspirations are only to the teens then this seems possible with some short-term holding of one's nerves, (and nose).
GLA
How many more shares are there in issue now than back in November 2019?