Nantkwest / Immunitybio -> IBRX WKN: A2QQ2E ISIN: US45256X1037 Kürzel: IBRX Forum: Aktien User: captainpump97

Glaubst du, dass ich mir das ausgedacht habe?

Wenn Du jemals mit der FDA zu tun gehabt hättest, dann wüsstest Du, dass die NIEMALS zu einer "Einreichung auf Zulassung" raten. Die sind da komplett spaßbefreit!

Was mich an der ganzen Sache viel mehr stört ist, dass nicht mehr erwähnt wird, dass die FDA ImmunityBio zu einer Einreichung auf Zulassung erst geraten hat und diese dann doch abgelehnt hat... Insgesamt bin ich bei dem Umgang mit der FDA hin und hergerissen, da ich Patrick schon verstehen kann, wenn er glaubt, dass ImmunityBio benachteiligt wird, aber dann nur noch auf der FDA rumzuhacken kann auch schnell zum Boomerang werden und genau das Gegenteil bewirken...

Wie ist hier eure Lesart? Trump scheint sich ja auf PSS Seite zu schlagen, ansonsten gäbe es dieses angedachte Treffen sowie auch die Präsenz beim Saudi Forum nicht (mehr). Prinzipiell sträube ich mich zwar gegen derartige politische Einflussnahme, aus Investorensicht ist dies aber grundsätzlich mal eher zu begrüßen würde ich sagen. Es sind zwar noch recht viele unbekannte Variablen (z.B. wie der FDA Chef Makaray dazu steht), aber dennoch gibt mir das Hoffnung für beschleunigte Zulassungen. Was meint ihr?

Ah, sorry, da hätte ich ja auch selbst schauen können, merci!

https://stkt.co/XJCkxtAL

https://www.msn.com/en-us/money/other/lawmakers-invited-to-fda-meeting-for-soon-shiong-s-drug/ar-AA1RCQdN?ocid=BingNewsVerp

Hab ich von Stocktwits - hoffentlich alles in der richtigen Reihenfolge reinkopiert 🤞🏻

He has a net worth of around $12 billion, according to a recent estimate by Bloomberg.

Soon-Shiong has expressed frustration that the FDA hadn’t approved Anktiva for a different form of bladder cancer from the one it’s already approved for. In 2021, ImmunityBio said Anktiva met its goal for treating that condition in a later-stage trial. Justin Zelin, a biotech analyst at BTIG, said getting the FDA to clear the drug’s use for more bladder cancer patients is “a real revenue opportunity” that could generate $1 billion in additional sales. The FDA has been skeptical about the drug. In early May, the agency sent ImmunityBio a “refusal to file” letter, a sign that the company’s application to expand the use of its cancer drug was not strong enough for an agency review. At the time, ImmunityBio said in a statement that it requested “an urgent meeting” with the FDA to resolve the issue. Soon-Shiong became rich by selling biotech companies. Forbes once called him “the richest doctor in the history of the world.”

Johnson said he’s met with Soon-Shiong several times about ImmunityBio, and that he wanted to attend the FDA review meeting because he was concerned that the agency is obstructing terminally ill cancer patients from accessing its drug. Johnson has been a longtime advocate for the Right To Try movement, which argues that dying patients should have access to unapproved medicines. “He’s got a therapy that looks really promising,” Johnson said in an interview. “I just don’t understand the roadblocks that they’re throwing up in front of them.” ImmunityBio’s share price had dropped 18% from the start of the year through Tuesday’s close. In 2014, Soon-Shiong founded ImmunityBio to focus on a promising area of medicine called immunotherapy, which trains the body’s immune system to recognize and destroy cancer cells.

Under the new Trump administration, the agency has faced criticism for appearing to merge drug reviews with political priorities. One of Makary’s signature initiatives is a program that allows the agency to speed up drug reviews if companies align with the administration’s priorities on domestic manufacturing, drug pricing or public health. In late November, Senator Bernie Sanders and House Representative Frank Pallone sent a letter to Makary, expressing concern that the program “will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump.” Last year, ImmunityBio’s drug Anktiva was approved in the US to treat some patients with bladder cancer. It competes against treatments from other drugmakers, including Merck & Co. and Johnson & Johnson. ImmunityBio wants to expand Anktiva’s use to treat other forms of cancer, including lung cancer.

An FDA spokesperson said the agency is committed to keeping the drug review process free of outside influence. “FDA’s long-standing process is to protect the independence and integrity of the scientific review process, a core tenet of the MAHA agenda,” an FDA spokesperson said, referring to the Make America Healthy Again movement. Dunn’s office and ImmunityBio did not respond to requests for comment. Political Pressure Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, said the review process is supposed to be based on balancing a drug’s safety and effectiveness, and that lawmakers could skew the outcome. “Their presence would create enormous pressure on FDA employees to approve a product,” Lurie said.

Johnson said he had planned to attend the review meeting that the company had scheduled, but that FDA officials underneath Makary “forcefully” objected to the senator’s attendance. Johnson plans to receive a readout of the meeting, and has suggested a follow-up meeting with him, Makary and Soon-Shiong. Soon-Shiong has been publicly pressuring the FDA to expand approval of Anktiva, an immunotherapy developed by his company ImmunityBio. The drug is currently cleared only for a specific type of bladder cancer, but Soon-Shiong has launched a publicity blitz to secure broader approval – across social media posts, podcast interviews and direct appeals to President Donald Trump. If the plan had gone forward, Johnson and Florida Representative Neal Dunn would have attended the drug review meeting on Dec. 3, according to the documents. ImmunityBio recently disclosed it had planned to meet with the FDA this month to discuss possible new approval routes for Anktiva.

Two Republican lawmakers were invited to attend a Food and Drug Administration meeting about the potential expanded approval of a drug backed by billionaire Patrick Soon-Shiong, but the plan was scrapped due to internal opposition at the agency. Wisconsin Senator Ron Johnson, one of the two lawmakers who were invited, said the meeting was about a drug made by ImmunityBio Inc., a company Soon-Shiong founded. FDA head Marty Makary was aware the lawmakers were invited to the meeting, according to documents reviewed by Bloomberg, though it’s unclear if he endorsed the move. The invitation was unusual for the FDA, whose regulatory process is supposed to be dictated by science rather than politics. Lawmakers have generally not been allowed to attend drug approval meetings to prevent the appearance of political interference in the review process, though the practice is not banned outright. It was unclear who extended the invitation to the lawmakers.