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Biotech / Medical : 2021 Biotech Stock Picking Charity Contest
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To: technetium who wrote (161)5/25/2021 9:49:42 PM
From: Aloner1 Recommendation

Recommended By
Lance Bredvold

   of 307
 
The FDA published Provention Bio Inc’s (NASDAQ: PRVB) teplizumab-related briefing documents ahead of an Advisory Committee meeting scheduled for May 27 (Thursday).

The agency sounded a relatively positive tone on safety and efficacy after identifying deficiencies that preclude discussion of labeling and post-marketing requirements.

The company seeks approval for teplizumab for the delay of progression to clinical type 1 diabetes (T1D) in at-risk patients.

The approval could make teplizumab the first disease-modifying therapy that preserves beta-cell function for patients with stage 2 of the disease who are at risk of progressing to stage 3 clinical T1D, stated the document.

In the pivotal TN-10 study, a single 14-day course of teplizumab was well tolerated and resulted in a 2-year delay in the progression to Stage 3 insulin-dependent T1D.

“The totality of the efficacy and safety data strongly supports the positive benefit/risk of teplizumab for the delay of progression to Stage 3 clinical T1D in at-risk patients with pre-symptomatic Stage 2 T1D,” according to the FDA document.

It was my understanding the FDA did not appreciate the original verbiage of "prevent", rather than "delay". I do not believe they "overstated the approval prospects", although "prevent" is a pretty strong word. I think the new briefing documents released today address that error in semantics, as does the stock price. Up another 8% after hours. I have no idea how the plethora of lawsuits will affect anything. It would seem "shareholder losses" are recovering rapidly. I am a shareholder and have opted to not participate in a lawsuit to date.
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