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Polarean Imaging (POLX) Share Price Rallied 5.51% as It Recovered From the FDA Crash

Updated: 13 Oct 2021

Polarean Imaging PLC (LON: POLX) share price rallied 5.51% as it recovered from the massive crash triggered by the FDA’s rejection of the company’s new drug application (NDA).

The imaging company’s share price fell after the US Food & Drug Administration (FDA) said that it could not approve the NDA in its current form and issued a list of issues that the company must address to improve the chances of approval.

Polarean applied for the approval of a drug-device combination product that uses hyper-polarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine.

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The company said it would seek to engage further with the FDA to get its drug-device combination approved in the shortest time possible.

Meanwhile, Polarean installed its 9820 xenon polariser system at the BC Children's Hospital in Vancouver on 11 September 2021. The system will be used to support the hospital's research into the paediatric pulmonary disease.

The recent installation provides evidence that Polarean understands how to utilise technologies based on xenon gas as the basis for its medical devices and treatments. Based on this, I would imagine that it is only a matter of time before the FDA approves the rejected NDA.

Polarean is working hard to meet the FDA’s requirements, leading to the commercialisation of its drug-device product soon.

The company’s shares have recouped almost half of their FDA-induced losses and are currently headed higher. Therefore, there is a good chance that the shares will recover to their pre-FDA highs in the future.

*This is not investment advice.

Polarean Imaging share price.

IG chart of Polarean imaging share price 13-10-2021

Polarean Imaging shares rallied 5.51% to trade at 67.00p, rising from Tuesday’s closing price of 63.50p.

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