The Food and Drugs administration has approved Bioelectronics Corp (OTCMKTS:BIEL) knee and Plantar Fasciitis studies as an indicative of musculoskeletal pain relief. However, the agency has also requested the company to carry out additional studies that will help substantiate broader indication of use.
Plans for Second Study
The company now plans to review back pain data generated from UK Registry studies. Given that studies on the trial device for musculoskeletal back pain were carried out on 4,500 subjects, the company believes it has enough data to meet the FDA’s request.
The meeting on the musculoskeletal back pain device comes just days after the company held another meeting with the FDA regarding the marketing clearance of its ActiPatch device. In a press release, BioElectronics says it handed the agency all the required review information and slides presented in the meeting to help in the review.
The FDA is expected to deliberate on the regulatory pathway for the ActiPatch device upon going through the material at hand. Early this month the regulator provided the clearest of indication that the 510K pathway for the device could be available upon review of the submitted data.
Stock’s Poor Performance
The company is relying on the series of positive news to make a comeback in the market after a poor run. Reaction to the news has so far been negative, the Street having reacted to calls for a new study for the back pain device by sending the stock crashing by 10%. With the crash coming at the back of 102 million shares trade volume, it seems investors are paying attention even to the smallest of news from the company.
The last thing Bioelectronics Corp (OTCMKTS:BIEL) needs is delays or setbacks in the launch of new products that have the potential to bolster its sentiments among investors. Red flags in the recent past have pushed its stock to all-time lows and in dire need of something that will help reinvigorate investor confidence for a bounce back.
Pluristem Therapeutics Inc. (NASDAQ:PSTI) Bullish Bets On The Rise
Pluristem Therapeutics Inc. (NASDAQ:PSTI) is closing in on its 52-week high in the market after a series of positive clinical trials news. The biotechnology company is in the process of initiating a Phase 1 trial for its lead drug PLX-R18, designed to treat patients who have undergone hematopoietic cell transplant.
Pluristem Therapeutics Inc. (NASDAQ:PSTI) announcing positive Phase II clinical trial on PLX-PAD for the treatment of Duchenne conditions also continues to bolster the stock’s sentiments on the street. Analysts at H.C Wainwright currently rate the stock as a buy with a share price target of $3.5. FBR Capital analyst, Vernon Bernardino has also weighed in on the stock reiterating an ‘outperform’ with a $3 share price target.