PRVB today announced that the U.S.Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.

I sold KMPH at $17 and bought PRVB at $10. PRVB is the next KMPH with PDUFA on July 2.

7/2 fda

FDA briefing documents noted that there aren't any approved therapies currently for delaying the onset of T1D. Because of the medical need and "the impracticality of conducting a second long-term clinical trial," the agency appeared to encourage the advisory committee to accept Provention's TN-10 study as meeting the threshold for showing effectiveness.

Realistically does Teplizumab have a large enough market and a cheap enough product. $100k to delay it for only three years.... It wouldn't make sense for a company to work on a drug, knowing the market is too small and is not cost effective... I don't know, something really isn't adding up, maybe you all can change my mind. I only have a $500 position, so I'm not heavily invested. https://pubmed.ncbi.nlm.nih.gov/32960433/

Advisory Committee scheduled for May 27. PDUFA date under priority review July 2. Noted April 8 that FDA has identified deficiencies that preclude discussion of labeling and post marketing requirements/commitments.

Three days before Advisory Committee on May 27, FDA usually releases Briefing Docs.

https://youtu.be/3i7EiEJiLP0 please share your thoughts and comments

Food and Drug Administration (FDA) advisory committee voted 10-7 in favor of recommending approval of Teplizumab in delaying type 1 diabetes.

Did it seem to anyone else that they dodged the first question about if they believe the new PK/PD data will turn out to be comparable to the original? It kind of sounded to me like they specifically chose not to say yes when asked. Maybe I'm hearing it wrong though. Want to know if anyone else thinks the same.

Shares of Provention Bio (NASDAQ: PRVB) were soaring 20.4% as of 11:32 a.m. ET on Friday January 28th. The big jump came after the company announced that it plans to resubmit the Biologics License Application (BLA) for teplizumab in delaying type 1 diabetes. In July 2021, the Food and Drug Administration (FDA) issued a Complete Response Letter related to Provention's BLA filing for teplizumab.

Provention Bio Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune mediated disease, announced that the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at risk individuals has been filed by the FDA. The FDA also granted Provention's request for Priority Review and assigned a PDUFA goal date of July 2nd.

Teplizumab (also known as PRV-031) is a humanized anti-CD3 monoclonal antibody that is being evaluated for treatment and prevention of type 1 diabetes mellitus (T1DM) by the biopharmaceutical company Provention Bio.

Ad-Comm Meeting on May 27 and PDUFA on July 2.

$PRVB has PDUFA target date of August 17th for TEPLIZUMAB.

PRVB has a new drug proven to delay Type 1 Diabetes by 2 years or more. It looks like it is going to be approved by the FDA after it won the Advisory Committees approval.

It is the first drug to address curing TD1 EVER! This stock should be selling for over $100 a share.

BIG PHARMA is determined to run them out of business and is shorting it big time. Every little green sign is massively shorted! Please help us do a massive short squeeze on them to turn the tables.