Simon has over six years of professional trading experience across FX, commodities and equities. He has a strong passion for financial markets and is particularly focused on price action trading
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.
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.
Polarean Imaging shares rallied 5.51% to trade at 67.00p, rising from Tuesday’s closing price of 63.50p.
Tech stocks offer some of the best growth potential, but time and time again, traders and investors ask us “what are the best tech stocks to buy?” You've probably seen shares of companies such as Amazon and Netflix achieve monumental rises in the past few years, but there are still several tech stocks with room for significant gains. Here is our analysts view on the best tech stocks to buy right now
CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage . 75 % of retail investor accounts lose money when trading CFDs with this provider . You should consider whether you understand how CFDs work, and whether you can afford to take the high risk of losing your money .