SBN 0.00% 0.0¢ sun biomedical limited

I've been doing some research into time-frames for approval of...

  1. 619 Posts.
    lightbulb Created with Sketch. 192
    I've been doing some research into time-frames for approval of devices as opposed to drugs by FDA> Drug approval can take years, but devices usually take less time, but average is around 6-12 months

    It seems we were all a bit ahead of ourselves by putting in a Jan 23rd expected approval date. It seems that these things take much longer than 90 days, and almost all of the products/devices I researched took around 6-12 months to get clearance, even longer for the first in the field devices. It seems that through past experience, the FDA will require further informationa and testing, and as this is a first-in-field device, they are extremely stringent.

    I still believe they will get the approval, but it will take much longer than originally anticipated. I would put a conservative date at around May - June

    What are you gonna do? At least they should get it, and being first oral device should really skyrocket the price. That is why FDA approval is so highly sought after and gets Share prices in companies flying, because of the long and difficult task it is to get it. But when you get it, the world is at your feet.

    Patience required, but long term view needed. Don't think the sp will do much in next 2 months. Probably drop back to 3 cents in short term before getting up over 10 in June

    Unfortunately, thats the way it is with these spec companies. Patience is the key.





 
watchlist Created with Sketch. Add SBN (ASX) to my watchlist

Currently unlisted public company.

arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.