Positief artikel omtrent Relief waarbij de koerscorrectie van vandaag als overdreven wordt bestempeld :
Article from TheMarket NZZ
Relief Therapeutics is not receiving emergency approval
The data from a first registration study for the Covid 19 drug Zyesami were apparently not robust enough for the US health authority. Relief Therapeutics, however, has a second arrow in its quiver.
December 30, 2020, 10:53 a.m.
Just before the end of the year, Relief Therapeutics ?? received unsolicited mail from the United States. The US health authority FDA informed the Swiss biotech company that it would not grant it emergency approval for the drug Zyesami (former name Aviptadil) for Covid 19 patients with a severe course and exhausted treatment options.
The application for emergency approval is based on the data of an open study with a total of 51 patients. They were published in October. At the time, patients who received Zyesami were found to be nine times more likely to survive. Studies are considered to be open if both the patient and the doctor know who is receiving the investigational drug and who is not.
That could also have been the reason for the reluctance of the FDA that has now been shown. "Although statistically significant, the data from the observational study presented today are not reliable," said Olav Zilian, pharmaceutical analyst at Mirabaud, on the occasion of the publication of the study data necessary for the application for emergency approval in October. "Proof of effectiveness can only be obtained in the context of a randomized controlled double-blind study."
As the investigator of a nonrandomized, uncontrolled study, Zilian said, you tend to give a drug to those patients who you hope it will work. Consciously or unconsciously, a selection for treatment with the new active ingredient takes place. Even with a nine-fold higher chance of survival, as determined by Relief, under this condition there is no evidence the drug works.
Nevertheless, today's setback is not that bad for the time being. Relief Therapeutics has just completed a second double-blind, randomized, controlled trial for Zyesami. No serious side effects were reportedly observed in the treated patients.
The company is now starting to evaluate the effectiveness data. She plans to publish them in late January or early February. The FDA has given assurances that it will review the data from this double-blind, randomized, controlled trial as soon as possible after submission.
This leaves everything open, both approval and none. Not much has changed in the current situation. The price decline of over 20% ?? today is exaggerated for me.
Nevertheless, the shares are only something for extremely risk-taking and above all risk-taking investors.
If approved, the Relief Therapeutics stocks still have significant potential, despite the steep price increase this year. The fight against Covid-19 may not be won with vaccines alone. Effective medication for those who are already ill is also needed as a protective aid.
However, if the FDA refuses to launch Zyesami, the price loss will be extremely painful. The value of Relief Therapeutics is based on the potential of the active ingredient against Covid-19 and thus on the principle of hope.
... seems TheMarket who has been sceptical in the past is changing it's opinion.