Possible Scenarios:
RSF Offensive Success ("Yes"): Low-Medium (25–35%) - Khartoum city center falls under the undisputed control of RSF. - Rapid Fall of El-Obeid (Late 2025), RSF secures offensive corridor with air defenses, and internal collapse of the SAF front.
Prolonged Stalemate ("No"): High (50–60%) - Khartoum remains under SAF control but under constant threat from RSF airstrikes. - SAF successfully defends El-Obeid, RSF faces logistical bottleneck, and Khartoum remains actively contested [Query Criteria].
De Facto Split ("No"): Medium (10–15%) - Due to military attrition, the RSF focuses on consolidating its control in the West (parallel government in Nyala) and avoids a major offensive on Khartoum. - The RSF does not attempt to capture the capital or the front line freezes in Kordofan.
I. Executive Summary and Probability Estimate
Probability Estimate (March 2026): The probability that the Rapid Support Forces (RSF) will regain sustained, effective, and undisputed control of Khartoum city center (Khartoum proper) is assessed as Medium-Low (25–35%) [Query Criteria].
Key Obstacle: The SAF (Sudanese Armed Forces)'s resistance in key areas (especially El-Obeid) and the RSF's logistical difficulties in attacking the center via long supply lines (LoC) increase the risk of the conflict reaching a stalemate.
Resolution Criteria: For the issue to be resolved with a "Yes" vote, only Khartoum city center, excluding Omdurman or Bahri, must be returned to the RSF's full and undisputed military control [Query Criteria].
II. Operational Situation and Strategic Shifts
SAF Recaptures Khartoum (March 2025): The SAF launched an offensive in late 2024, recapturing the city center of Khartoum and securing full control, including the presidential palace and government buildings, by March 2025. By May 2025, Khartoum province was declared fully liberated.
SAF Success: This success was achieved thanks to the SAF's capture of Al-Jazirah province, cutting off the RSF's supply routes, and utilizing allied militias such as the Baraa Bin Malik Battalion.
RSF Counter-Strategy: The RSF described the withdrawal from the center as "strategic" and instead focused on conducting long-range airstrikes on SAF targets in and around Khartoum using FH-95 kamikaze drones provided by the UAE.
III. Western Front: Kordofan's Decisiveness
Fall of El Fasher (October 2025): The RSF's capture of El Fasher, the last SAF stronghold in Darfur, consolidated all of Darfur. This victory solidified the RSF's logistical power in the West and its dominance of economic resources such as the gold trade.
Operation Kordofan: The center of gravity of the conflict shifted to Kordofan, the gateway to Khartoum. The RSF recaptured the strategic town of Bara on the Darfur-Khartoum supply route.
The "El Obeid Test": The ongoing battle for El Obeid, the capital of North Kordofan and the SAF's central logistics base, is the single most important determinant of an RSF offensive on Khartoum. To capture Khartoum by March 2026, the RSF must capture El Obeid by the end of 2025.
IV. External Support and Logistical Stalemate
Balance of External Support: The conflict has devolved into a proxy war, with both sides receiving external support. This prevents a rapid collapse and fosters a protracted war of attrition.
RSF Supporters: Primarily the UAE (drones and anti-aircraft systems).
SAF Supporters: Weapons and military systems provided by Turkey (Bayraktar TB-2s, missiles) and Iran (drones). Egypt has increased coordination around El-Obeid.
Air Superiority: The SAF's secure supply line from Port Sudan maintains its logistical superiority. However, the RSF's long-range drone attacks constantly threaten the SAF's logistics centers in Khartoum and El-Obeid. Neutralizing SAF air superiority in the Kordofan corridor is essential for a successful RSF offensive.
Why do you think you're right?
Time Constraint: The 147-day period for authorization is shorter than the minimum 150- to 270-day review period for the De Novo classification pathway, which is required for initial LLM devices due to the lack of legal precedent.
Increased Depth of Review: Generative Artificial Intelligence (GenAI) systems are subject to a complex and in-depth review, with the Predetermined Change Control Plan (PCCP) published in August 2025 to manage unique risks such as "hallucinations" and "model drift."
High Risk Alert: The Digital Health Advisory Committee (DHAC) meeting in November 2025 increased oversight of LLMs, raising the possibility of extensive requests for additional information that would halt the review clock, particularly for high-risk applications.
Chance of Success: The only theoretical way to obtain authorization in this tight timeframe is if the application is submitted very early (before November 2025) and is a low-to-medium risk workflow optimization tool in areas like radiology, avoiding high-risk therapy claims.
* https://www.complizen.ai/post/de-novo-fda-pathway-complete-guide
* https://www.complizen.ai/post/samd-510k-vs-denovo-vs-pma
* https://www.jdsupra.com/legalnews/fda-s-digital-health-advisory-committee-2069955/
* https://www.psychiatrictimes.com/view/fda-committee-meets-on-generative-ai-digital-mental-health-devices
* https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
* https://www.raps.org/news-and-articles/news-articles/2025/11/medical-groups-make-recommendations-for-fda-regula
* https://intuitionlabs.ai/articles/ai-radiology-trends-2025
Why might you be wrong?
To receive authorization by March 31, 2026 (i.e., within approximately 147 days), the LLM-based medical device must simultaneously meet the following critical requirements:
Some Details:
The Only Scenario That Will Achieve Approval: Low-Risk Workflow LLM
For an LLM device to receive approval within this tight timeline, it must navigate a very low-friction regulatory pathway and have an application already well advanced. The key requirements for this "Perfect Application" scenario are:
1. High-Quality and Early Filing (Timeliness)
Early Filing: The application must be submitted to the FDA before the forecast window opens on November 4, 2025, in early September or October 2025. The de novo pathway (mandatory pathway for new devices) has a minimum review time of 150 to 270 days. Meeting the 147-day deadline requires a review in near-record time with zero or very short pauses.
eSTAR Efficiency: The application must be submitted using the electronic application template (eSTAR), which became mandatory for De Novo applications starting October 1, 2025. This saves time by eliminating early-stage delays (RTA) in the review process due to application incompleteness.
2. Low-Risk Clinical Focus (Application Area)
Low Clinical Friction: The device should avoid high-risk diagnostic or therapeutic claims. Because the Digital Health Advisory Committee (DHAC) meeting in November 2025 focuses on high-consequence areas like digital mental health, LLMs in these areas will immediately be subject to additional review (Request for Additional Information (AI) and will miss the timeline.
Workflow Optimization: For the best chance of success, the LLM should be a tool used solely for workflow optimization (e.g., report drafting, summarizing patient history) in a field like radiology, where the FDA already has many traditional AI approvals. This will be seen as the least novel clinical intervention and minimize regulatory resistance.
3. Flawless Regulatory Compliance Process (Technology)
PCCP Preparation: The application must include a robust Predetermined Change Control Plan (PCCP) to manage the LLM's continuous learning and adaptation, in accordance with guidance finalized in August 2025. The FDA will rigorously review this methodology to ensure the safety and effectiveness of future changes to the model.
Zero Defects: Any "Request for Additional Information" (AI) received from the FDA during the review process stops the review clock and is not added to it. Therefore, for approval to occur by March 2026, the application must be nearly perfect the first time and have no significant flaws that would stop the review clock.
In summary, there is a chance, but only if a company (probably already experienced in radiology) has submitted the application months in advance, has applied for a low-risk workflow application, and has perfectly met all the new regulatory requirements (such as PCCP) necessary to manage the complex nature of the LLM.
* https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program
* https://www.complizen.ai/post/de-novo-fda-pathway-complete-guide
* https://www.complizen.ai/post/samd-510k-vs-denovo-vs-pma