Here’s why the Paradigm Biopharmaceuticals Ltd (ASX:PAR) share price is sinking on Monday morning…
The post Why the Paradigm (ASX:PAR) share price is sinking 5% today appeared first on The Motley Fool Australia. –
The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price has started the week in the red.
In morning trade, the clinical stage biopharmaceutical company’s shares are down just under 5% to $2.44.
Why is the Paradigm share price sinking lower today?
Investors have been selling Paradigm’s shares this morning after it provided an update on its dealings with the US Food and Drug Administration (FDA).
This is in relation to its investigational new drug (IND) application to the FDA for the proposed pivotal clinical trial treating subjects with pain associated with knee osteoarthritis (OA).
Paradigm previously revealed that it submitted its over 30,000 page IND application to the FDA on Friday 26 March.
This morning the company revealed that it has received a few questions from the FDA during the current 30-day IND review period. Positively, those questions were answered by Paradigm within 48 hours of receipt.
However, on Friday 23 April, Paradigm received a verbal indication from the FDA that the regulator would be putting further questions to Paradigm outside the 30-day IND review period.
The release explains that the FDA was unable to provide all questions within the initial IND review period and has advised it will submit them to Paradigm within the next 30 days.
Many of the questions, based on the brief discussion the company had with the FDA, are related to newly submitted non-clinical data.
Disappointingly, this could delay proceedings and lead to the company falling behind schedule on its plan to enrol clinical trial subjects.
Nevertheless, management advised that Paradigm is ready to review and answer questions when they are received. Once in receipt of Paradigm’s responses, the FDA will review them within 30 days.
Following today’s decline, the Paradigm share price is now trading a disappointing 37% lower than its 52-week high of $3.88.
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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.