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Thanks, good board here.
Financial Times - Mergers & Acquisitions
https://markets.ft.com/data/equities/tearsheet/profile?s=APHD:PKC
Agreed.
“Once the contract is signed and announced, the share price could move quite a bit, so we encourage readers to follow closely every announcement made by the company. It will be a great catalyst for the stock.” Source: https://insiderfinancial.com/appiphany-technologies-holdings-corp-otcmktsaphd-making-a-comeback
PSTI - U.S. FDA Grants Fast Track Designation to Pluristem's PLX-PAD for the Treatment of Critical Limb Ischemia (CLI)
•Pluristem’s Ongoing Phase III CLI trial has been selected for accelerated approval pathways in both the U.S. and Europe
•Fast Track Designation allows for expedited review of drugs to treat serious conditions with unmet medical need
HAIFA, ISRAEL, September 18, 2017 -- Pluristem Therapeutics, Inc. (NASDAQ:PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.
“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need” said Zami Aberman, Chairman and Co-CEO of Pluristem.
“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay.
Pluristem’s Phase III CLI study is ongoing and actively enrolling patients in the U.S. and Europe. The European Medicines Agency (EMA) has included PLX-PAD in its Adaptive Pathways program. Positive results from an interim analysis following treatment of half (125) of the study’s population may lead to early conditional marketing authorization. In Japan, the Pharmaceuticals and Medical Devices Agency (PDMA) has accepted PLX-PAD for the treatment of CLI into its accelerated regulatory pathway for regenerative therapies and has agreed on the design of a single study (N=75) that may lead to early conditional marketing approval and reimbursement.
the next PR/News will include but not limited to:
1. quarterly reports to bring NOUV to pink current info
2. update on finalization of paperwork to change its name from Nouveau Life Pharmaceuticals to better reflect its business strategy and operations.
3. update in regards to developing exclusive regional sales teams to market energy savings plans implemented by best of class service providers similar to a franchise model in 480 territories.
4. update in regards to being approached by several entities that are ready to sign up, get trained and start selling,"
a lot to look forward to.
NOUV
agreed. Acquisition news on BOLO
APHD is changing its name and preparing for the acquisition news. imo, the past few trading sessions with BMIC and VNDM was to help pay for that. BMIC and VNDM is "taking a backseat" to me means that announcement news is any day now. just my thoughts.
you're welcome. looking for greens days going forward.
APHD
The pps were absolute gifts the past couple of days.
Agreed Curt. News is coming and when it does, this train will be unstoppable.
$APHD
the remainder of the week and the weeks ahead will be very exciting.
APHD
something well worth doing in my humble opinion...lock up your shares with a high sell order so that there will be fewer shares out there for shorty to borrow and bring down the pps. And don't forget to move your limit order up when the price starts to recover, then, that way your shares can't be shorted.
with the size of APHD's float, if a large number of holders did this, it would reduce the overall amount of shares that they could get their hands on. the ask is so thin that it literally moves on air.
I have my sell order set at 0.10 for now. GLTYA
$APHD
i absolutely agree with that assessment cj.