Stefan Bernstein explains how the EU/Greenland critical raw materials partnership benefits GreenRoc. Watch the full video here.
FDA's priority review voucher (PRV) programs are about drug development, and specifically the time and cost of drug development and the conditions a new drug is intended to treat.
Developing a new drug is a costly and time-intensive affair. The cost of developing a new drug can range from the tens of millions to billions of dollars—and that assumes the development program is successful. Only about one in 10 drug products which enter phase I testing are ever approved in the US. For some hard-to-treat indications, like conditions affecting the central nervous system, success rates can be even lower.
The time it takes to obtain that approval can also be a major factor. Companies often take years, sometimes decades, to develop a drug before sending it to regulatory officials for review. Once FDA begins its review, it takes more than a year on average for regulators to approve a drug.
FDA's priority review vouchers (there are three types) are incentives meant to spur the development of new treatments for diseases that would otherwise not attract development interest from companies due to the cost of development and the lack of market opportunities.
To do this, companies are given a special voucher which allows them to have any one of their drugs reviewed under FDA's priority review system.
Here’s a flow chart of the process. It says can take 6 months to issue a voucher.
https://twitter.com/kaneinthename/status/1722309061398450313/photo/1
https://www.raps.org/news-and-articles/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know
Three patients experienced progression free survival (PFS) more than 180 days
One patient remains on treatment more than one year.
Median PFS is historically 1.5-6 months
This is fantastic news!!
https://twitter.com/kaneinthename/status/1720862104800899104
Https://twitter.com/kaneinthename/status/1720358769522065678
https://youtu.be/amXeCGFkbSQ?si=ZFnyrNb8bNYtOl-r
Well stated by
@AlMusella
- "If all of the contrast enhancing tumor is removed at surgery, the chance of 2 year survival jumps to 40%."
IB Delta T1 maps clearly delineate enhancing tumor for surgeons.
https://virtualtrials.org/newsarticle.cfm?item=8508
@theABTA
@NBTStweets
@CNS_Update
@NeuroOnc
Another step forward in bringing innovative therapies to patients with #GBM - we submitted a Fast Track designation request to the FDA for oral gallium maltolate. Fast Track is an expedited approval pathway for agents that treat serious conditions & address unmet clinical needs.
How long is Fast Track FDA approval?
within sixty days
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Not long to wait!
Further more RJH27 I just had a look at your last posts strangely you’ve only posted on the Iqai thread and the tone of every comment is negative. Do us all a favour and go f i n g e r y o u r a s s w I t h a s c e n t e d c a n d l e
Probably going to get a ban for that but it’s worth it lol!
If you read the eligibility criteria you will see the fact they are applying for FDA fast track means they are are obviously meeting one/all of the eligibility criteria. But you should already know this considering it was in the recent shareholder letter or you’ve just shown to everyone on the board that you’re only here to troll and attack posters adding information that could help other REAL investors. Hopefully from now on people won’t read your drivel!!
GLA!!
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that qu
London Cyber Attack Halted Trading |
The London Stock Exchange suffered an outage that curbed trading in hundreds of small-cap shares on Thursday.
The group said it was investigating “an incident” in which investors could only trade shares in the FTSE 100 and 250 indices and global depositary receipts, a certificate representing shares in overseas companies.
The outage was a further blow for the LSE, which has struggled to attract new listings this year amid a global downturn.
Information provided by several news sources including FT.
No information has been provided on the nature of the attack.
https://ft.com/content/a69a01e7-0351-4465-932d-2ac420351a6d
GE HealthCare Awarded a $44 Million Grant to Develop Artificial Intelligence-Assisted Ultrasound Technology Aimed at Improving Outcomes in Low-and-Middle-Income Countries
Grant from Bill & Melinda Gates Foundation will facilitate development of AI-assisted applications and tools to enable healthcare professionals with less experience to perform quick and accurate ultrasound scans to help address maternal and fetal health and respiratory diseases
AI-assisted ultrasound algorithms will be developed to run on multiple ultrasound devices to expand access to high quality care around the world with an emphasis on low-and-middle income countries (LMIC)
CHICAGO -- GE HealthCare (Nasdaq: GEHC) today announced it received a grant from the Bill & Melinda Gates Foundation for more than $44 million to create user-friendly, artificial intelligence (AI)-assisted ultrasound imaging auto-assessment tools. These tools will seek to aid healthcare professionals—even those without specialized training or experience with ultrasound—with clinical decision information to support more effective obstetric and lung screening ultrasound scans across maternal and fetal care as well as pediatric lung health, with a goal of expanding access to low-and-middle income countries (LMIC) and across diverse sites of care.
From Friday rns
Finally, funding from current NIH grants continues and new funding opportunities are being explored. It is through these grant collaborations with top academic centers that result in the translation of ground-breaking treatments into routine clinical care. We have identified a large new grant opportunity that is specific to our core imaging technologies, and we are evaluating potential aims for a February submission.
Would be great if we could also get a grant from bill gates. Dishing out some of his covid profits lol!!
GLA!!
Shares of Tempest Therapeutics Inc. TPST soared nearly 4,000% on Wednesday after the company released study results for its investigational cancer treatment TPST-1120 in patients with liver cancer.
The drug candidate, in combination with the Roche Holding AG RHHBY treatments Tecentriq and Avastin, showed clinical superiority as a first-line treatment for unresectable or metastatic hepatocellular carcinoma, a common type of liver cancer, Tempest said in a release Wednesday.
Further to the announcement made on 18 August 2023, IQAI has cancelled the 396,241 ordinary shares issued to the Mayo Clinic. Following this cancellation, the issued share capital is now 182,225,149 ordinary shares.
I’m signing off for the foreseeable future this game is hard enough to get your head around without games being played by significant holders. They say one thing and do the other. Today’s actions do not give personal investors confidence and are the exact opposite to what we as shareholders were told in an rns.
“The key drivers are all shareholders, who have had to become accustomed to the vagaries of the stock market and how it values the Company`s shares. Oftentimes the market capitalization of the Company has changed over a small number of trading days by 10-25% without any discernable reason”
“We believe that the cumulative accretion of value during this time is not adequately reflected in the current market valuation of the Company, and we are now considering how best to address this anomaly.”
Is this one of those “vagaries” or is it an “anomaly” it would be great if you could update the “ALL SHAREHOLDERS” on why we should buy your company shares while you and your family sell?
Picked up another 580k on the drop, thank you very much!!
Dr. Christopher Chitambar, MD, Emeritus Professor of Medicine and Biophysics, Division of Hematology and Oncology at MCW is the Chair and Co-principal investigator of the study and, along with Co-principal investigator Dr. Jennifer Connelly, MD, Associate Professor of Neurology at MCW, will be enrolling patients in the study. Both are long-standing collaborators with Kathleen Schmainda, PhD, a co-founder of IB and a recognised leader in brain tumour imaging. Together they have researched and developed the use of GaM in preclinical GBM trials. Since the advanced brain tumour imaging offered by IQAI is needed to monitor treatment efficacy for this trial, the investigators approached the Company as a natural partner to provide resources and expertise for this Phase 1 clinical trial.
From the first announcement about the trial
I was told recently. When they have something substantive to say they will and can’t say much more at present in regards to a question about an update on zero G.
This statement from the final results rns makes me think we are due an update soon on this. Probably submission of de novo application .
Using patented artificial intelligence ("AI") technology, IB Zero G generates enhanced "with contrast" images using only non-contrast (0% gadolinium) images as input. The FDA's response to the FDA 510(k) submission concluded that IB Zero G™ was too novel and unique a product and subsequently directed IB to pursue a different regulatory clearance pathway. IB is compiling additional documentation in preparation for a pre-submission meeting with the FDA and plans to submit a "de novo" application in the second half of the year. The de novo request is a market clearance pathway designed for novel medical devices for which no legally marketed predicate device exists to demonstrate substantial equivalence.
This is also from previous updates
In response to how well patients are tolerating the agent and to meet the goal of the phase 1, defining the MTD, the clinical team is preparing an amendment to the original study protocol. The amendment will expand the targeted enrolment from 24 to 36 subjects and allow for continued dose escalation. The MTD determined in Phase 1 will define the "recommended phase II dose" (RP2D) that will be used in the Phase 2 trial. This amendment is the fastest and most efficient way to satisfy the primary goal of the Phase 1.
Given the expanded target enrolment and assuming the strong momentum in patient enrolment continues, it is anticipated that Phase 1 will close in 2024. After enrolment closes, the last patients enrolled will remain on the trial until all required study data is collected. Analysing the data and documenting the phase 1 results is expected to be completed in the second half of 2024.
While the MTD is being determined in the final stages of Phase 1, the clinical team will complete the Phase 2 protocol. The Phase 2 trial is designed to evaluate preliminary evidence of efficacy. Ideally, the Phase II trial will open for patient recruitment in early 2025. This will be a multi-centre trial with a tentative target enrolment of approximately 65 patients over a three-year duration. The design of the Phase 2 study is currently being defined. Factors such as the Phase 1 results and whether the study will be a comparison to historical controls or if it will be randomized (comparing patients with standard treatment alone against those receiving standard treatment with GaM) will influence the overall scope and cost.
The multi-site Phase 2 trial will require new funding which we anticipate will come substantially from a partnership arrangement with a large pharmaceutical company and grants, including those from charitable foundations and other institutions. We anticipate publishing frequent updates to our shareholders as developments unfold.