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[6-K] RedHill Biopharma Ltd. Current Report (Foreign Issuer)

Filing Impact
(Low)
Filing Sentiment
(Neutral)
Form Type
6-K

RedHill Biopharma reported receipt of a Nasdaq Staff Determination for continued non-compliance with the minimum stockholders’ equity requirement under Listing Rule 5550(b)(1). The company notes the minimum threshold is $2.5 million and says that, following its transaction with Cumberland Pharmaceuticals announced October 20, 2025, it believes equity now exceeds that level.

RedHill intends to appeal to a Nasdaq Listing Qualifications Panel, which may determine that compliance has been regained or grant up to a 180-day extension. Submission of a hearing request will stay any delisting or suspension action, and RedHill’s American Depositary Shares remain listed and traded on the Nasdaq Capital Market pending the Panel’s decision. The company cautions there is no assurance of a favorable outcome or an extension.

RedHill Biopharma ha comunicato di aver ricevuto una determinazione dello staff Nasdaq per la continua non conformità al requisito minimo di patrimonio netto degli azionisti ai sensi della Listing Rule 5550(b)(1). La società segnala che la soglia minima è $2,5 milioni e afferma che, a seguito della transazione con Cumberland Pharmaceuticals annunciata il 20 ottobre 2025, ritiene che l’equità ora superi tale livello.

RedHill intende presentare ricorso a un Nasdaq Listing Qualifications Panel, che potrebbe determinare che la conformità sia stata ripristinata o concedere un’estensione fino a 180 giorni. L’invio di una richiesta di udienza sospenderà qualsiasi azione di delisting o sospensione, e le American Depositary Shares di RedHill rimangono quotate e negoziate sul Nasdaq Capital Market in attesa della decisione del Panel. L’azienda avverte che non vi è alcuna garanzia di esito favorevole o di un’estensione.

RedHill Biopharma informó haber recibido una Determinación del personal de Nasdaq por incumplimiento continuo del requisito mínimo de patrimonio de los accionistas bajo la Regla de Listado 5550(b)(1). La compañía señala que el umbral mínimo es $2.5 million y afirma que, tras su operación con Cumberland Pharmaceuticals anunciada el 20 de octubre de 2025, cree que el patrimonio supera ahora ese nivel.

RedHill tiene la intención de apelar ante un Panel de Clasificación de Nasdaq, que podría determinar que se ha recuperado el cumplimiento o conceder una extensión de hasta 180 días. La presentación de una solicitud de audiencia suspenderá cualquier acción de retirada de cotización o suspensión, y las American Depositary Shares de RedHill continúan listadas y negociadas en Nasdaq Capital Market mientras espera la decisión del Panel. La empresa advierte que no hay garantía de un resultado favorable ni de una extensión.

RedHill Biopharma는 Listing Rule 5550(b)(1)에 따른 주주 자본 요건의 지속적 비준수에 대해 Nasdaq 직원 결정서를 받았다고 발표했다. 회사는 최소 임계치가 $2.5 million이며 2025년 10월 20일 발표된 Cumberland Pharmaceuticals와의 거래에 따라 현재 자본이 그 수준을 상회한다고 설명한다.

RedHill은 Nasdaq Listing Qualifications Panel에 항소할 의향이 있으며, 패널이 규정 준수를 회복했다고 판단하거나 최대 180일의 연장을 부여할 수 있다. 청문 요청 제출은 상장폐지 또는 일시 중지 조치를 유예하며, 패널의 결정이 나올 때까지 RedHill의 미국 예탁증권(ADR)은 Nasdaq Capital Market에서 상장되고 거래된다. 회사는 유리한 결과나 연장에 대한 보장을 할 수 없다고 경고한다.

RedHill Biopharma a déclaré avoir reçu une détermination du personnel de Nasdaq pour non-conformité continue à l’exigence minimale d’avoir des actionnaires conformément à la règle de cotation 5550(b)(1). La société indique que le seuil minimum est $2.5 million et affirme que, suite à sa transaction avec Cumberland Pharmaceuticals annoncée le 20 octobre 2025, elle estime que les capitaux propres dépassent désormais ce niveau.

RedHill a l’intention de faire appel devant une Nasdaq Listing Qualifications Panel, qui peut déterminer que la conformité a été rétablie ou accorder une extension allant jusqu’à 180 jours. La soumission d’une demande d’audience suspendra toute action de radiation ou de suspension, et les American Depositary Shares de RedHill restent cotées et négociées sur le Nasdaq Capital Market en attendant la décision du Panel. La société avertit qu’il n’y a aucune garantie d’un résultat favorable ou d’une extension.

RedHill Biopharma berichtete über den Erhalt einer Nasdaq-Mitarbeiter-Entscheidung wegen fortgesetzter Nichteinhaltung der Mindestaktienkapitalanforderung gemäß Listing Rule 5550(b)(1). Das Unternehmen stellt fest, dass der Mindestschwellenwert $2.5 million beträgt und erklärt, dass es nach der am 20. Oktober 2025 bekannt gegebenen Transaktion mit Cumberland Pharmaceuticals glaubt, dass das Eigenkapital jetzt dieses Niveau übersteigt.

RedHill beabsichtigt, Berufung bei einem Nasdaq Listing Qualifications Panel einzulegen, das entscheiden kann, dass die Einhaltung wiederhergestellt wurde, oder eine Verlängerung von bis zu 180 Tagen gewähren kann. Die Einreichung eines Anhörungsantrags hat suspensive Wirkung gegenüber etwaigen Delistings oder Suspendierungen, und RedHills American Depositary Shares bleiben bis zur Entscheidung des Panels an der Nasdaq Capital Market gelistet und gehandelt. Das Unternehmen weist darauf hin, dass es keine Garantie für ein günstiges Ergebnis oder eine Verlängerung gibt.

RedHill Biopharma ذكرت استلام قرار من موظفي ناسداك بسبب الاستمرار في عدم الامتثال لمتطلب الحد الأدنى لحقوق المساهمين وفقاً لقاعدة الإدراج 5550(b)(1). تشير الشركة إلى أن الحد الأدنى هو $2.5 million وتقول إنه، عقب المعاملة مع Cumberland Pharmaceuticals المعلنة في 20 أكتوبر 2025، تعتقد أن حقوق الملكية تتجاوز هذا المستوى الآن.

تنوي RedHill تقديم استئناف إلى لجنة مؤهلات الإدراج في ناسداك، التي قد تقر بأن الامتثال قد استعيد أو تمنح تمديداً يصل إلى 180 يوماً. إن تقديم طلب جلسة استماع سيوقف أي إجراء لسحب الإدراج أو التعليق، وتظل أسهم RedHill الأمريكية المدرجة والمتداولة في Nasdaq Capital Market حتى قرار اللجنة. تحذر الشركة من أنه لا توجد ضمانة لنتيجة إيجابية أو لتمديد.

RedHill Biopharma 报告收到 Nasdaq 员工决定,因持续未符合上市规则 5550(b)(1) 的最低股东权益要求。公司指出最低门槛为 $2.5 million,并表示,在 2025 年 10 月 20 日宣布与 Cumberland Pharmaceuticals 的交易之后,其权益现在已超过该水平。

RedHill 打算向 Nasdaq 上市资格委员会提起上诉,该委员会可能认定已重新达到合规,或授予最长 180 天的延期。提交听证申请将中止任何退市或暂停行动,RedHill 的美国存托股票(ADR)在委员会决定之前仍在 Nasdaq Capital Market 上上市并交易。公司警告称,不能保证结果有利或获得延期。

Positive
  • None.
Negative
  • Nasdaq Staff Determination for equity non-compliance under Rule 5550(b)(1) with potential delisting risk

Insights

Nasdaq non-compliance triggers appeal; listing stays pending hearing.

RedHill disclosed a Nasdaq Staff Determination tied to Listing Rule 5550(b)(1) concerning the minimum stockholders’ equity threshold of $2.5 million. The company states that, after its transaction with Cumberland Pharmaceuticals, it believes equity now exceeds that threshold, a factor that could support its appeal.

The appeal goes to a Nasdaq Panel, which can affirm regained compliance or provide up to a 180-day extension. Filing the hearing request stays delisting or suspension, so the ADS remain on the Nasdaq Capital Market until a decision.

The key risk is that the Panel may not grant an extension or find compliance restored. Actual impact turns on the Panel’s determination, as explicitly acknowledged by the company.

RedHill Biopharma ha comunicato di aver ricevuto una determinazione dello staff Nasdaq per la continua non conformità al requisito minimo di patrimonio netto degli azionisti ai sensi della Listing Rule 5550(b)(1). La società segnala che la soglia minima è $2,5 milioni e afferma che, a seguito della transazione con Cumberland Pharmaceuticals annunciata il 20 ottobre 2025, ritiene che l’equità ora superi tale livello.

RedHill intende presentare ricorso a un Nasdaq Listing Qualifications Panel, che potrebbe determinare che la conformità sia stata ripristinata o concedere un’estensione fino a 180 giorni. L’invio di una richiesta di udienza sospenderà qualsiasi azione di delisting o sospensione, e le American Depositary Shares di RedHill rimangono quotate e negoziate sul Nasdaq Capital Market in attesa della decisione del Panel. L’azienda avverte che non vi è alcuna garanzia di esito favorevole o di un’estensione.

RedHill Biopharma informó haber recibido una Determinación del personal de Nasdaq por incumplimiento continuo del requisito mínimo de patrimonio de los accionistas bajo la Regla de Listado 5550(b)(1). La compañía señala que el umbral mínimo es $2.5 million y afirma que, tras su operación con Cumberland Pharmaceuticals anunciada el 20 de octubre de 2025, cree que el patrimonio supera ahora ese nivel.

RedHill tiene la intención de apelar ante un Panel de Clasificación de Nasdaq, que podría determinar que se ha recuperado el cumplimiento o conceder una extensión de hasta 180 días. La presentación de una solicitud de audiencia suspenderá cualquier acción de retirada de cotización o suspensión, y las American Depositary Shares de RedHill continúan listadas y negociadas en Nasdaq Capital Market mientras espera la decisión del Panel. La empresa advierte que no hay garantía de un resultado favorable ni de una extensión.

RedHill Biopharma는 Listing Rule 5550(b)(1)에 따른 주주 자본 요건의 지속적 비준수에 대해 Nasdaq 직원 결정서를 받았다고 발표했다. 회사는 최소 임계치가 $2.5 million이며 2025년 10월 20일 발표된 Cumberland Pharmaceuticals와의 거래에 따라 현재 자본이 그 수준을 상회한다고 설명한다.

RedHill은 Nasdaq Listing Qualifications Panel에 항소할 의향이 있으며, 패널이 규정 준수를 회복했다고 판단하거나 최대 180일의 연장을 부여할 수 있다. 청문 요청 제출은 상장폐지 또는 일시 중지 조치를 유예하며, 패널의 결정이 나올 때까지 RedHill의 미국 예탁증권(ADR)은 Nasdaq Capital Market에서 상장되고 거래된다. 회사는 유리한 결과나 연장에 대한 보장을 할 수 없다고 경고한다.

RedHill Biopharma a déclaré avoir reçu une détermination du personnel de Nasdaq pour non-conformité continue à l’exigence minimale d’avoir des actionnaires conformément à la règle de cotation 5550(b)(1). La société indique que le seuil minimum est $2.5 million et affirme que, suite à sa transaction avec Cumberland Pharmaceuticals annoncée le 20 octobre 2025, elle estime que les capitaux propres dépassent désormais ce niveau.

RedHill a l’intention de faire appel devant une Nasdaq Listing Qualifications Panel, qui peut déterminer que la conformité a été rétablie ou accorder une extension allant jusqu’à 180 jours. La soumission d’une demande d’audience suspendra toute action de radiation ou de suspension, et les American Depositary Shares de RedHill restent cotées et négociées sur le Nasdaq Capital Market en attendant la décision du Panel. La société avertit qu’il n’y a aucune garantie d’un résultat favorable ou d’une extension.

RedHill Biopharma berichtete über den Erhalt einer Nasdaq-Mitarbeiter-Entscheidung wegen fortgesetzter Nichteinhaltung der Mindestaktienkapitalanforderung gemäß Listing Rule 5550(b)(1). Das Unternehmen stellt fest, dass der Mindestschwellenwert $2.5 million beträgt und erklärt, dass es nach der am 20. Oktober 2025 bekannt gegebenen Transaktion mit Cumberland Pharmaceuticals glaubt, dass das Eigenkapital jetzt dieses Niveau übersteigt.

RedHill beabsichtigt, Berufung bei einem Nasdaq Listing Qualifications Panel einzulegen, das entscheiden kann, dass die Einhaltung wiederhergestellt wurde, oder eine Verlängerung von bis zu 180 Tagen gewähren kann. Die Einreichung eines Anhörungsantrags hat suspensive Wirkung gegenüber etwaigen Delistings oder Suspendierungen, und RedHills American Depositary Shares bleiben bis zur Entscheidung des Panels an der Nasdaq Capital Market gelistet und gehandelt. Das Unternehmen weist darauf hin, dass es keine Garantie für ein günstiges Ergebnis oder eine Verlängerung gibt.



 UNITED STATES   
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
  
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
 
For the month of October 2025
Commission File No.:001-35773
 
REDHILL BIOPHARMA LTD.
(Translation of registrant’s name into English)
 
21 Ha'arba'a Street, Tel Aviv, 6473921, Israel
(Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.  

Form 20-F         Form 40-F 
 
Attached hereto and incorporated by reference herein are the following:

Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: “RedHill Biopharma Receives Nasdaq Staff Determination Notification”.

This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No. 333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001), on June 20, 2024 (File No. 333-280327) and on March 25, 2025 (File No. 333-286082), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on August 9, 2024 (File No. 333-281417).


SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
REDHILL BIOPHARMA LTD.
 
 
(the "Registrant")
 
 
 
 
 
Date: October 22, 2025
By:
/s/ Dror Ben-Asher
 
 
Name:    
Dror Ben-Asher
 
 
Title:
Chief Executive Officer
 






Press Release


RedHill Biopharma Receives Nasdaq Staff
Determination Notification

On October 16, 2025, the Company received a Staff Determination notification from The
Nasdaq Stock Market LLC regarding continued non-compliance with the minimum
stockholders’ equity requirements for continued listing, pursuant to Listing Rule 5550(b)(1)
--
Following RedHill’s transaction with Cumberland Pharmaceuticals Inc., announced October
20, 2025, the Company believes that its stockholders’ equity now exceeds the minimum $2.5
million requirement and that it is well positioned to maintain compliance
--
The Company intends to appeal Staff’s determination to a Hearings Panel, pursuant to the
Nasdaq Listing Rule 5800 Series and present its case. The Panel has the authority to
determine whether the Company has regained compliance or to grant up to a 180-day
extension to regain compliance
--
Submission of a hearing request will stay any delisting or suspension action of the
Company’s American Depositary Shares, and RedHill remains listed and traded on the
Nasdaq Capital Market, pending the hearing
--
There can be no assurance that the Panel will grant an extension of the compliance period or
that the outcome of the hearing will be favorable to the Company

TEL AVIV, Israel and RALEIGH, NC, October 22, 2025, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that on October 16, 2025, it received a Nasdaq Staff Determination letter indicating that the Company had not met the minimum stockholders’ equity requirements (“Minimum Equity Requirement”) for continued listing, pursuant to Listing Rule 5550(b)(1), by the required compliance date of October 13, 2025.

The Company intends to appeal Staff’s determination at a hearing before the Nasdaq Listing Qualifications Panel (the “Panel”) and present its position.  The Panel has the authority to determine whether the Company has regained compliance or grant up to a 180-day extension to regain compliance.

On April 17, 2025, Nasdaq notified the Company that it was no longer in compliance with the Minimum Equity Requirement and on August 8, 2025, Nasdaq granted an extension letter granting the Company additional time until October 13, 2025, to regain compliance.



Following RedHill’s transaction with Cumberland Pharmaceuticals Inc., announced October 20, 2025, the Company believes that its stockholders’ equity now exceeds the minimum $2.5 million and that it is well positioned to maintain compliance.

The submission of a hearing request will stay any delisting or suspension action of the American Depositary Shares. RedHill remains listed and traded on the Nasdaq Capital Market pending Nasdaq Panel decision.

There can be no assurance that the Panel will grant an extension or that the outcome of the hearing will be favorable to the Company.

About RedHill Biopharma  

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults1. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn’s disease (based on RHB-104’s positive Phase 3 Crohn’s disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America.

More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.



Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding the strategic transaction with Cumberland and are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Staff Determination Notification from the Nasdaq LLC may not be withdrawn and that the Company may be delisted from the Nasdaq Capital Market; the risk that the strategic transaction with Cumberland will not bring the currently anticipated benefits to RedHill’s global Talicia business or to RedHill’s financial position, costs or its broader strategic objectives; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
 
Company contact:
 
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
 
Category: Corporate
 

1 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: https://www.talicia.com/.

FAQ

What did RedHill Biopharma (RDHL) disclose in this 6-K?

It received a Nasdaq Staff Determination for non-compliance with the minimum stockholders’ equity requirement under Listing Rule 5550(b)(1).

What is the minimum stockholders’ equity threshold relevant to RDHL?

The company cites a minimum stockholders’ equity requirement of $2.5 million under Listing Rule 5550(b)(1).

How does RedHill plan to respond to the Nasdaq notice?

It intends to appeal to the Nasdaq Listing Qualifications Panel, which can confirm compliance or grant up to a 180-day extension.

Is RDHL still listed on Nasdaq during the appeal process?

Yes. Submission of a hearing request will stay any delisting or suspension action, and the ADS remain listed and traded pending the Panel’s decision.

What role does the Cumberland Pharmaceuticals transaction play?

RedHill believes that, following the transaction announced October 20, 2025, its stockholders’ equity now exceeds $2.5 million.

Is a favorable outcome guaranteed for RDHL’s appeal?

No. The company states there is no assurance the Panel will grant an extension or deliver a favorable decision.
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