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Sorry was not a question, was an affirmation!
Hgen is saying that they expect to received TLD in Q2 (we all know) but also they expect to submit to MHRA in Q2 with PPQ+TLD! Huge news IMO.
I was not expecting them to be able to submit TLD +PPQ in next ~50 days and restart the MA clock time !
TLD and submission PPQ+TLD to MHRA in Q2?
"Topline results from ACTIV-5/BET-B are expected to be released in the second quarter of 2022. If confirmatory of the findings of the CRP subgroup from the Company’s LIVE-AIR study, the Company plans to include the results from ACTIV-5/BET-B in an amendment to its Emergency Use Authorization (“EUA”) submission to the
U.S. Food and Drug Administration (“FDA”), and to include these results in a responsive submission to Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom along with certain performance process qualification (“PPQ”) data around drug product batches, in the second quarter of 2022."
Hi !
I'm trying (in different boards) to have a overview of the UK situation, but I can't find an answer. Maybe here I can find some biotech experts to help :)
Humanigen stated that Drug Substance PPQ has been completed since Feb 17th (corporate deck from feb) and Drug Product PPQ is in progress since then.
Does anyone have an idea how long it would take to complete the PPQ Drug Product ? Or even to finished a product once the bulk substance is already available?
More then 2,5 months have passed, so trying to open the discussion about UK.
Thanks !
Isn't it already ? So f. for life
I deleted it quickly, because maybe it was not my place to share it. But it is on LinkedIn for those wondering, he seems fine now, but wishing him good luck, and a well recovery.
Now at least we understand why he was not signing the PR
Lessons learned? Not to me I think, Insiders canceled options deal, im still not selling lol
I wish I was not buying while dale was selling
My pleasure to share good news !!
Have you seen the Q&A?
"What are the criteria for selecting the ten therapeutics?
•Soundness of scientific approach and technology used (pharmacological rationale): available evidence of potential role of medicinal product.
•Stage of development: progress in development of medicinal product.
•Availability of relevant clinical outcome results from clinical trial(s).
•Absence of (new) major identified safety issues that would question the suitability of the product in the proposed indication.
•Unmet clinical need and/or therapeutic added value.Efficacy against new SARS-CoV-2 variants (relevant only for some product categories).
•Suitability of the product for the particular healthcare setting: related to route of administration, treatment regimen, formulation, etc.
•Intention to engage at an early stage with EMA to obtaining scientific advice (to apply for an EU marketing authorisation).
•Candidate therapeutics already within the regulatory process: potential COVID-19 medicinal product is currently undergoing evaluation by EMA or is under rolling review.
•Overall impact the product might have in COVID-19 treatment.
•Likelihood of success both to achieve the desired impact and to be authorised in the European market.
•Time needed until entry into the European market.
•Diverse portfolio approach: beyond the individual merits of each therapeutic candidate, the portfolio as a whole needs to cover the whole spectrum of COVID-19 and all COVID-19 product categories of new or repurposed medicinal products."
Thanks Jay, we will see. Hope you are right :)
I don't think we are scheduled for 1h50 though, the PR talks about from 1h15 to 2h45, this is just the time for the entire Breaking news session, according to ICIS schedule
Hi Jay, I'm not finding our presentation during tomorrow breaking news event. Where are you seing it ?
Scheduled Presentations:
08:15 - 08:30
BioLegend: What’s new from BioLegend for ICIS/Cytokines 2021?
08:30 - 08:45
ICIS - Learn about opportunities for Cytokines 2022 in Hawaii! / IVICT - PeptiGrowth - Growth factor alternative peptides
08:45 - 09:00
Cytokine Signalling Forum - An overview of the Cytokine Signalling Forum / Olink - Next generation proteomics / Quanterix - High definition multiplex measurement of cytokines & interferons with Simoa®
09:00 - 09:15
10X Genomics - High resolution characterisation of the immune system / GSK - Live discussion with immunology network postdoc / PBL - Human interleukin products providing accurate endogenous quantitation
09:15 - 09:30
Pfizer Post-doctoral program / Xilio - Learn more about Xilio Therapeutics
09:30 - 09:45
Boehringer Ingelheim Pharmaceuticals opnMe.com: The open Innovation portal of Boehringer Ingelheim / Korean Association of Immunologists (KAI) supports Young Investigators! / Luminex - The new xMAP® INTELLIFLEX: Technology you trust. Versatility you want.
In the presentation deck there is a bullet point about: UK Scientific Advisory Board on October 14 (?)
Thank you, 4don :)
That would be great! In my head I had that korea would recruit 20 pts, but I cannot find that info anymore. Do you have any source for the 50 pts ? Thanks!
If we increase the pace, hopefully. If we use the September's pace it leaves us with end of the year estimate. But.. Saint Louis University (Missouri) has also started recruiting for activ-5 today!
Last call CD said around 50 pt enrolled in Sept on top of the 330 previously announced. That put us at around 380 pt (69%) enrolled. Hoping that the ~65% from the presentation is on the conservative side :)
It's not free... They are choosing shares instead of their base salary. Which is good, they are saving hgen money.
On the other hand, it is only me that see "in a effort to save cash" as an small indication that Q3 results will be bad, since fda decision came toooo late?
Thanks, but it's not working for me, after registration it is showing: this event has ended
Missed it and it is not available anymore, hgen will share the video soon in their website. Curious to hear your thoughts, though :)
Thank you for this detailed explanation :)
As an antiviral is it variant dependant ?
They have just done it, we have just received the PR.
"#Humanigen submits all planned modules for potential conditional marketing authorization from the UK’s MHRA. A copy of the full press release is available on IR website. https://t.co/Pl7tmC3pvJ"
Oups, 2 minutes earlier hehe
Nothing yet, what do you thing ?
Why do you think is it not material, if you don't mind elaborating it.
It was supposed to be the last one, it is on the presentation deck as part of one of the 12 months goals.
Why they would chose to not PR that, have we indeed submitted it? It was really the last one?
Thanks
Any thoughts about the fact that CD said multiples times that they will be submitting the last module for the rolling review before the end of the month and we haven't heard about it yet ?
He even used at the last conference, the word "certainly" before the end of this month.
Still expecting a PR tomorrow PM, but I was really thinking they would annonce it today..
I totally agree that the second paragraph should be different and more personalized, including the phrase from hgen PR "...unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19".
I was just saying, that we must have received the same boilerplate end. It's frustrating, that they use this same language (provide us more data) for other drugs that for sure have more risks than benefits for covid.
Imho I think that we received a standard phrase like this one from another fda rejection letter :
"FDA remains committed to fostering the development and availability of potential
treatments for COVID-19. Despite FDA declining to issue an EUA for
hydroxychloroquine sulfate at this time, FDA remains committed to working with you
and other interested parties in the development of products to prevent or treat COVID-
19. If and when additional data become available, such as data from randomized
controlled trials, that you believe is adequate to enable FDA to conclude that the known
and potential benefits outweigh the known and potential risks of this product, you can
submit a new EUA request to FDA at that time. We will review any such submission
promptly.
Forward all future EUA-related communications, in triplicate, identified by the above pre-
EUA number, to the following address:"
We received an answer with the presentation deck. Up 550 patients total, but targeting 400 with crp < 150 for the primary endpoint. I'm good with these 400 :)
I agree with those theories, it does not make sense to change the primary outcome and still enroll crp >150. Hope is just a website update, but still why they cannot keep that right.
Primary outcome is limited to CRP <150 and age < 85
"Time to ventilation or death in subjects with a baseline score of 5 or 6.
Subjects in ordinal scores 5 or 6 at baseline with a CRP<150 mg/L at baseline and age<85 years, where the event is described as being in one of these two categories: Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death "
But the question is still there, are they still enrolling people with CRP > 150 or age >85 since those criterias are not in the inclusion/exclusion population?
How the primary outcome has those filters but not the enrolling ?
Is this means that we may have 500 patients total but way less patients used for the primary outcome?
Don, what do you think about the comment that crp is not in the inclusion/exclusion criteria of patients. Is that means that they will still enroll patients with crp >150 and only exclude them from the primary endpoint ?
Yes but when they added the criteria for CRP <150, there were less then 200 patients enrolled. So if now we are enrolling 500pt, we can assumed that at minimum the new 300 pt will have CRP < 150. And, for the first 200 patients at least some of them will also have this criteria. In hgen trial they reached with 300ish pt an pvalue of 0.003, why do you thing that now they cannot reach stat sig ?
How can they have new results earlier if we have not yet enrolled nih target ?
An important positive aspect is they will filter by crs <150. And the p-value for those patients in liveair was way lower than the 0.03
Anyone has reached management today? Any news ? :)
Concerns about the financial aspect? I now that we had +100M in cash at the end of Q2. But, as confirmed yesterday per Jay they continued producing all Q3. How much of cash burn for Q3 are you expecting ?
Thanks Don, lets overthink again,lol.
If they expect to have the trial enrolled by the end of the year and to apply for BLA at the beginning of 2022, how can they expect to reapply for eua earlier than BLA? Is it possible to have access to NIH partial results (example 300pt) ?
I was blinded too..
If fda is concerned about jak inhibitors heart-related issues and blood clot issues can this decline be about the fact that Lenz showed higher cardiac arrest (8 patients for lenz (3%) vs 4 placebo (1.6%)) and higher pulmonary embolism (5 patients for Lenz (2.0%) vs 3 placebo (1.2%)) than placebo?
"FDA Drug Safety Podcast on required warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions"
"for a new eua request". So this means wait for activ-5 enrollment, plus results traitement, plus re-submission, plus 100+days of analysis.. ?