The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
FDA Review and Response:
The FDA reviews the RPDD application and, if additional information is required, may request clarification or additional data from the sponsor. The FDA aims to respond to the sponsor within 60 days of receiving the application (FDA, 2023e).
Upon approval of a product with RPDD, the sponsor receives a PRV. This voucher can be used by the sponsor to expedite the FDA review of another product which reduces the review time from 10 months to 6 months (FDA, 2023c). The PRV is also transferable so the sponsor can sell or transfer the voucher to another sponsor (FDA, 2023c). This incentive encourages sponsors to invest in the development of therapies for rare pediatric diseases as the PRV can potentially offset the high costs associated with the development of such treatments.
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For those who don't know:
PRV is Pediatric Disease Priority Review Voucher - the FDA awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, or alternatively, sold or transferred.
PRV's have been bought for between $53 million to $350 million*. Basically a bigger pharma buys the PRV for =/- $100 million and can use it on one of its formulations. The more desperate the pharma is to fast-track its drug, the more it will pay.
August 2023
Krystal Biotech - sold its PRV for $100 million
2022
Novartis buys FDA priority review voucher from bankrupt Mallinckrodt for $100M
2022 & 2023
Bluebird Bio sold TWO PRVs for $102 million and $95 million respectively
July 2023
Sarepta Therapeutics has sold a priority review voucher for $102 million
June 2023
Pharming sold PRV for to Novartis for $21.1 million (pre-agreed) price - worth 5 times + that much if not pre-agreed
2022
Marinus Pharmaceuticals sold its PRV for $110 million
(* - More than 20 PRVs have been sold to date - for more info: https://www.venable.com/insights/events/2023/08/current-issues-in-fda-priority-review-voucher)
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If IB is successful in applying for an RPD-PRV, the vouchers can be transferred (sold) to other companies and the trading price of a PRV, per KIDS V CANCER (givekidsachanceact.org), is averaging $100 million.
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Earlier this year, we made the strategic decision to apply for a Current Procedure Terminology (CPT) code specific to the DSC perfusion technology available in IB Neuro. CPT codes are assigned and maintained by the American Medical Association (AMA). They are used to track and bill medical services for payer reimbursement. Like regulatory clearance, CPT codes are a critical aspect in achieving widespread commercial adoption in healthcare. Currently, a few of our clients are using a general, non-specific CPT code to get reimbursed for the MRI procedures that rely on IB Neuro, but only a limited few. This lack of a reimbursement pathway makes it more difficult for hospital administrators to justify investing in IB products. Fortunately, enough scientific and clinical validation have been performed by our co-founder, Kathleen Schmainda, PhD and her colleagues over the years, and a growing number of sites are routinely using IB Neuro as the standard of care, to warrant a dedicated CPT code. The application is due in early November and a final decision will be made in May 2024. A CPT code will help make for easier buying decisions for healthcare administrators.
IB Clinic Deployment
Steady progress is being made in the deployment of IB Clinic; both in terms of direct sales and through our established partnerships. We are encouraging our long-standing clients to migrate from our legacy, manual, and Mac-based platform, and upgrade to our platform-independent and automated IB Clinic application. This upgrade is being well received as it addresses the many challenges facing busy radiology departments around the world. For example, it consolidates needed information on a single dedicated workstation and creates a one-stop-shop for busy radiologists, it reduces the number of workstations requiring support from IT personnel, and it offloads MR Technologists who no longer have to manually process the information.
These gains in clinical efficiency dovetail perfectly with our strategy of making IB products accessible on larger, more comprehensive platforms, such as those offered by GE Healthare, Bayer, TeraRecon, and our other partners. Currently, we are working very closely with each of them in preparation for a busy tradeshow season. And, as you can imagine, all our partners share in our excitement of potentially receiving a CPT code for IB Neuro.
IB Nimble
Our development team has made tremendous enhancements to our handheld / mobile application, IB Nimble. Specifically, the code base is being re-engineered to enable widespread distribution and efficient support. More work remains, but interest is steadily growing from other brain (mets) cancer centers. As promised, we also deployed IB Nimble for use in a new disease group, metastatic bone cancer, at the Medical College of Wisconsin (MCW). We anticipate at least one more installation in Q4 2023.
Also, we just accepted an invitation to participate in a new initiative launched by the American
Interesting reads on GE and its AI journey:
https://www.fool.com/investing/2023/04/24/ge-healthcare-is-set-to-ride-the-ai-trend-heres-wh/
https://www.gehealthcare.co.uk/campaigns/research/ai-insights
and if you are a subscriber to the WSJ:
https://www.wsj.com/articles/ge-healthcare-makes-push-into-artificial-intelligence-136cb509
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Thank you!
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Thank you!
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Back in February: "IQ-AI Ltd. shares rose 23% on Tuesday after the company said it has received orphan drug designation status from the U.S. Food and Drug Administration for its treatment for brain cancer."
Are we expecting the same here?
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FDA grants orphan status to Gallium Maltolate for treating ATRT
Total Voting Rights
Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI), today announces the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of atypical teratoid rhabdoid tumour (ATRT). Currently the prognosis for patients with ATRT is dismal due to the lack of effective treatments.
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Apparently, there are 70 in use/ordered in the UK - Siemens.
Question - do they use Gadolinium?
www.dailymail.co.uk/health/article-12595463/New-3D-body-scanners-huge-step-forward-treating-cancer-dementia-illnesses-health-chiefs-say.html
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Wow. That was a bit of a roller coaster .. down by 10% ... ended up by 2%.
I need a lie down ...
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Www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1156843/full
Worth a read
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A soon-to-be-published @SignifyResearch report states that 5 billion diagnostic imaging procedures were performed globally in 2022 (the most since the pre-pandemic decline) & projected to exceed 6 billion by 2026 - driven by innovation & increased investments in medical imaging.
-- is industry therefore worth around USD 500 billion (average USD100 a prodecure)?
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Flying Brands Ltd was dissolved in 2015 ... was TB's previous vehicle.
IQ-AI was incorporated in 1993 in Jersey.
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Https://www.dotmed.com/news/story/61239
He likes it!
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I believe we already do have one ... ?
nasdaq.com/market-activity/stocks/iqaif
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From TB in RNS ... "our patented artificial intelligence technology" ... AI tech ... is the now and future ...
Medical AI (and education) is leading the way.
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Https://mailchi.mp/imagingbiometrics/ib-newsletter-edition-17568243
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Https://twitter.xxx/IQAI_IB/status/1699801486405038497
The primary goal of the EAF151 Phase II multi-site trial is to evaluate if @IQAI_IB 's DSC MRI (IB Neuro) can non-invasively predict which recurrent GBM patients will respond to Bevacizumab – optimizing treatment on a personalized level!
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