In morning trade the Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is tumbling lower and on course to end the week on a disappointing note.
At the time of writing the biopharmaceutical company’s shares are down 6% to $3.45.
Despite this decline, Paradigm’s shares are still up a remarkable 213% from $1.10 this time last year.
Why is the Paradigm share price tumbling lower today?
Investors have been selling Paradigm’s shares despite it providing a positive update on its U.S. activities.
According to the release, the company has just held a positive and informative pre-investigational new drug application (IND) meeting with the US Food and Drug Administration (FDA).
The meeting took place at the FDA offices in Washington and was attended by several of the Paradigm team and consultants. The two parties met to discuss the development and market authorisation plans for injectable Pentosan Polysulfate Sodium (iPPS) for the treatment of symptomatic osteoarthritis.
In the Pre-IND meeting, Paradigm’s team discussed its clinical, pre-clinical, and CMC (Manufacturing) data with the U.S. regulator. Details of these discussions will be released at a later date when the company receives the final minutes from the FDA.
Paradigm’s Chief Executive Officer, Paul Rennie, appeared to be pleased with how the meeting went and the feedback the company received.
He said: “The team and I are pleased with the positive feedback from the FDA at the Pre-IND meeting that took place yesterday. Paradigm looks forward to providing a more detailed update to the market once the final minutes of the meeting have been received.”
In the meantime, the company advised that development plans are proceeding towards an IND filing by the fourth quarter of calendar year 2020. It remains fully funded for the proposed Phase 3 Clinical Trial.
Whilst this was a positive update, it doesn’t appear to have been enough to offset a bearish broker note out of Morgans this week.
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