Why is the Firebrick Pharma share price blazing 28% on Wednesday?

Firebrick shares are having a strong day on Wednesday…

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The Firebrick Pharma Ltd (ASX: FRE) share price has been on form on Wednesday.

At one stage today, the clinical-stage pharmaceutical developer's shares were up 28% to 32 cents.

The Firebrick share price has since given back the majority of these gains but remains up 8% to 27 cents.

What's going on with the Firebrick share price today?

Investors have been bidding the Firebrick share price higher today despite there being no news out of the company.

However, it worth noting that prior to today the company's shares were trading 67% lower than their 52-week high.

So, with many beaten down ASX shares rebounding strongly today as investor sentiment improves, it isn't overly surprising to see Firebrick having a positive session.

Investors buying today appear optimistic that the company's Nasodine nasal spray still has a bright future despite being dealt a blow by the Therapeutic Goods Administration (TGA) earlier this month.

What happened to Nasodine?

Nasodine, a nasal spray intending to treat the common cold, was previously denied approval by the TGA.

The TGA then reaffirmed its stance earlier this month when the company received written advice from the regulator indicating that the section 60 request had resulted in confirmation of the original decision.

However, the company isn't accepting this and is now seeking to overturn this decision by applying for an independent review through the Administrative Appeals Tribunal (AAT).

Firebrick's executive chairman, Dr Peter Molloy, commented:

The s60 decision was always a possibility and we will now proceed to the next step in the appeal process. We strongly believe that the existing clinical data satisfactorily establishes the efficacy of Nasodine in the treatment of the common cold and that the AAT review should lead to an earlier approval of Nasodine.

We believe that because overall cold severity was not designated as the "primary" endpoint, the TGA has discounted the results.

No timeframe has been given for when a decision on the appeal will be made.

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. 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 Scott Phillips.

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