Medifirst Solutions Inc. (fka MFST)

[Baxy]

This makes total sense now as to why this has been a slower process than most have been hoping for:

The FDA does not give advance notice or define a timeline during their evaluation for 510(k) clearance. The process could take any number of months with no guarantee of success. Generally, when 510(k) clearance is granted, an early stage medical device company, such as Medifirst, is required to put together an infrastructure, including (i) new office space, (ii) instituting FDA controls and procedures, (iii) fine-tuning manufacturing, (iv) building and executing on a sales strategies, (v) producing custom-made cases and packaging for the medical device, and (vi) aligning all staffing, consulting and personnel needs. As Medifirst was aware that the FDA time frame was unknown and 510(k) clearance was not guaranteed, it was the Company's best judgment to delay the aggressive expansion of its operations and production before successfully receiving clearance to begin sales. Regarding sales, we presented our laser and established business relationships in Morocco, China, Asia, Mid-East and other international countries and markets. The international markets, although requiring complicated registration processes and ground work, offer the opportunity for large bulk sales which would be very beneficial for the Company's growth. Medifirst believes it has made significant progress in setting up a sales and corporate infrastructure and continues to advance these efforts further.
Read more at http://www.stockhouse.com/news/press-releases/2017/07/14/medifirst-solutions-answers-questions-from-shareholders#X1Iosu0T07Kl8r6A.99