It would have been better if company have included the update about how company is going with the response of 11 points clarification of FDA De Nova application and expected week/ month company will be responding to FDA.
Expected clearance of FDA 510K is now changed to first 4 to 5 months of 2019. I was expecting that company would have already submitted first FDA 510K application in January 2019. Again no indication of expected application submission date.
CFO last working day was 31 Dec and Company Controller (replacement of CFO) is also leaving as of 8 Feb. Company is not receiving any revenue and shouldn’t be much financial functions to perform on day to day basis. I strongly suggest 3 roles (Co Sec, CFO and Company Controller) should be merge into 1 role ( CFO/ Co Sec).
Cash as of 31 Dec is $2.2 million.Anticipated cash available for use by company is $6.8 million.Expected cash outflow in March quarter is $2.5 million and if they burn another $2.5 million by June quarter. We will be back to where we are right now. Company needs to review the spend and bring down quarterly cash outflow to under $1.5 million.
Management should seriously review their strategy. I understand obtaining FDA 510K is a priority at the moment but we already have TGA and CE Mark clearance, while we are in the process of obtaining FDA clearence. MediBio should use channel partners and hire few resources in UK and Australia to commercialise already approved products. UK is a big market and I wonder UK was never included in the last 2 previous Investor presentations.
MEB Price at posting:
1.9¢ Sentiment: Buy Disclosure: Held
