Ampliphi Biosciences Corp (NYSEMKT:APHB) has proclaimed the positive feedback they got from the U.S. based Food and Drug Administration (FDA) on their second phase of their development plan. As a result, the company will retain its H.C. Wainwright and Co. LLC to offer the company and its directors on the way forward in reviewing the alternative strategic goals.
The company, which provides therapies for a variety of drug-resistant bacteria infections, received encouraging results from the FDA on their detailed development proposals that they submitted earlier. The progress will now all the company to proceed with their second phase trial using Bacteriophage technology which includes a cocktail of AB-SA01 substance that would be useful in treating the notorious antibiotic-resistant Staphylococcus aureus (S. aureus) infections in patients suffering from the chronic rhinosinusitis (CRS).
The feedback from FDA was affirmed after the Type B telephonic meeting that took place in February this year. According to FDA officials, the phage therapy that was proposed by the Ampliphi is one of the thrilling and unique approaches to curing of a wide range of multidrug-resistant organisms and believed the company is capable and committed to addressing the exceptional regulatory disputes that could arise during the stages of product development.
The company has already reviewed the current status of its resources, internal programs, and capabilities to take up the challenge. The firm is exploring a variety of alternative strategies that could enable them to maximize the value of their shareholders. In the past two years, the company has managed to commence the world’s first cGMP facility which is devoted to manufacturing high-quality phage cocktails drugs. They also produced the necessary phage materials needed for to complete phase I of the trials. These generated positive results paving way for more research into patients that do not respond well to the conventional antibiotics.
The company will work along with the highly-experienced team from H.C. Wainwright and Co to make use of their world known expertise to identify and evaluate the alternative opportunities available for the company. At the moment, Ampliphi will not disclose the timelines for the explored strategic alternatives until the project matures.
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