Following the FDA's and EMA's advice and recommendations, the following are the main items implemented in the study design and the interim readout: The primary endpoint for the interim analysis will be identical to the full study endpoint, a comparison between the PLX-PAD treated group and the placebo treated group of the number of days from randomization to occurrence of major amputation of the index leg or death. psti $8.97 -$0.13 -1.4% Price as of August 7, 2020, 4:30 p.m. EDT View Interactive PSTI Charts PSTI News: Current Report Filing (8-k) 07:37 AM: PSTI News: Pluristem Expands its COVID-19 Program to Europe, Receives PEI Clearance to Commence Phase II Study in Germany: 07:00 AM: PSTI News: Statement of Changes in Beneficial Ownership (4) 08/03/2020 06:22:09 PM: PSTI News: Statement of Changes in Beneficial Ownership (4) 07/30/2020 07:14:13 PM © 2020 Market data provided is at least 10-minutes delayed and hosted by "Fly Insider: Montrose, Centene among week's notable insider transactionsPluristem price target raised to $16 from $12 at JefferiesPluristem expects current resources to support operations for over three yearsPluristem sees results from Phase I study of PLX-R18 in 1Q21Pluristem sees data from U.S. PLX-PAD study in COVID-19 in Q4Pluristem sees results from PLX-PAD study in muscle regeneration in 3Q21Pluristem expects interim data analysis from Phase III study of PLX-PAD in Q4Pluristem CEO says 'continuing to advance' regenerative medicine candidates Pluristem Therapeutics, Inc. Common Stock (PSTI) Stock Quotes - Nasdaq offers stock quotes & market activity data for US and global markets. Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today issued an … We do not expect a significant change in the number of enrolled patients required to complete the 82 events. "CEO Yaky Yanay said, "Over the last few months, we held discussions with the U.S. Food and Drug Administration and the European Medicines Agency to reaffirm understandings related to the interim readout of our global pivotal Phase III study of PLX-PAD in CLI. Forty patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome will be enrolled in the study. We are heading towards a pivotal year with four clinical readouts, on multiple opportunities for success in advancing PLX product candidates towards registration with applicable regulatory agencies.
The interim process and possible outcomes: An analysis of the interim data will have three possible outcomes: a) an earlier than planned end-of-study may be achieved if the top line interim data analysis achieves overwhelming efficacy (p less than or equal to0.01), b) the study may be declared futile if there is no probability of successfully achieving the primary endpoint on the full data set after enrolling all patients, or c) the study is in line with the protocol assumptions and considered to be in a promising zone for success. All of this leads Howerton to increase his CLI odds of success assumption to 30% from 25%, he noted.CEO Yaky Yanay said, "Pluristem had approximately $59M in cash and cash equivalents as of June 30, 2020. All of this leads Howerton to increase his CLI odds of success assumption to 30% from 25%, he noted.CEO Yaky Yanay said, "Pluristem had approximately $59M in cash and cash equivalents as of June 30, 2020. We expect that our current resources, together with the funds expected from the European Investment Bank, assuming all agreed milestones are achieved, will support our operations for over three years. "Pluristem Therapeutics issued an update to its shareholders from its CEO and President, Yaky Yanay. Export data to Excel for your own analysis. RTT News | April 24, 2020. We expect that our current resources, together with the funds expected from the European Investment Bank, assuming all agreed milestones are achieved, will support our operations for over three years. Learn everything you need to know about successful options trading with this three-part video course.Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools:You have already added five stocks to your watchlist. The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study. Enter your email address below to receive a concise daily summary of analysts' upgrades, downgrades and new coverage with MarketBeat.com's FREE daily email newsletter. In addition, we are finalizing our discussions with Germany's health regulatory agency, the Paul Ehrlich Institute, in order to launch a study in Europe. The entire Pluristem team is dedicated to success, and I would like to make sure all of you are aware of important milestones ahead of us. We expect to announce top line interim data analysis results during the fourth quarter of calendar 2020. "CEO Yaky Yanay said, "For our Phase III trial of PLX-PAD in muscle regeneration following hip fracture in the U.S., Europe and Israel, we have enrolled more than 60% of the 240 patients planned for the study and we expect to complete enrollment by the end of calendar 2020.
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