% | $
Quotes you view appear here for quick access.


  • stocktrak761 stocktrak761 Aug 15, 2013 11:43 AM Flag

    FDA on their final stage of making decision?

    What exactly does that mean? how close are we ? Months? days? years? Nanosecond?

    Sentiment: Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • He said on the cc they expected a response in Q3.

    • years ..up to 18 in some cases...average 3-5 !'s called an FDA / NDA

      they are in step 6 - Review 6 -24 months

      step 7 - post approval study (ANY minor issue and it's OVER!)

      i suggest you learn these things before stepping into highly speculative stocks ...more than a 85% rejection rate in the first application process....GTHP will now drift lower until a clearer picture emerges...

      Going nowhere fast!

      Since our inception, we have raised capital through the private sale of preferred stock and debt securities, public and private sales of common stock, funding from collaborative arrangements, and grants.

      Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception and, as of June 30, 2013, we had an accumulated deficit of about $96.8 million. To date, we have engaged primarily in research and development efforts. We do not have significant experience in manufacturing, marketing or selling our products. Our development efforts may not result in commercially viable products and we may not be successful in introducing our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue through at least the end of 2013 as we continue to expend substantial resources to introduce LuViva, further the development of our other products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance org

    • During the CC Mark Faupel expressively said "We are on the verge of hearing from the FDA"

0.0356+0.0006(+1.71%)1:32 PMEDT