InVivo to amend INSPIRE protocol, up to 40 new patients to participate; shares slump 6% on efficacy implications [Seeking Alpha]
InVivo Therapeutics Holdings Corp. (NVIV)
Last invivo therapeutics holdings corp. earnings: 5/7 04:30 pm
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US:NASDAQ Investor Relations:
invivotherapeutics.com/investor-relations/press-releases
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Source: Seeking Alpha
Thinly traded micro cap InVivo Therapeutics ( NVIV ) eases on modestly higher volume in response to its announcement that it intends to amend the protocol for the Phase 3 INSPIRE study evaluating its Neuro-Spinal Scaffold in patients with acute spinal cord injury. The company says the change will allow the recruitment of an additional 20 - 40 patients who were initially rejected because they did not meet all the inclusion criteria. It plans to submit the amended protocol to the FDA this quarter. Frequently, a study sponsor increases enrollment when interim data aren't as robust as desired. According to ClinicalTrials.gov, the estimated final data collection date for the primary efficacy endpoint is June, which InVivo says will not change due to the additional treatment arm. Now read: Ingrezza Label Gives Neurocrine A Competitive Edge »
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NVIV
Sec Filings
- 2/14/24 - Form SC
- 2/13/24 - Form SC
- 2/7/24 - Form 4/A
- NVIV's page on the SEC website