Guided Therapeutics Set to File Amended PMA Application for LuViva® Advanced Cervical Scan After “Productive” Face-to-Face Meeting with FDA
Business Wire Guided Therapeutics, Inc.
May 14, 2014 8:05 AM
NORCROSS, Ga.--(BUSINESS WIRE)--
Guided Therapeutics, Inc. (GTHP) (GTHP) today announced that as a result of its “productive” discussion with officials of the U.S. Food and Drug Administration (FDA) last week, the Company plans to submit an amendment to its premarket approval (PMA) application for the LuViva® Advanced Cervical Scan. The filing will include responses to questions raised in the agency’s September 6, 2013 not-approvable letter.
“The purpose of the meeting was to present the agency with our proposed answers to questions raised by FDA in the September letter and to help clarify our final responses,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA. We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days.”
Once submitted, the FDA will have 180 days to respond to the company’s submission. Additional dialogue with FDA is expected as the company proceeds toward PMA approval.
May 14, 2014
Guided Therapeutics to submit admendment to PMA for LuViva
Guided Therapeutic announced that as a result of its “productive” discussion with officials of the U.S. FDA last week, the company plans to submit an amendment to its premarket approval application for the LuViva Advanced Cervical Scan. The filing will include responses to questions raised in the agency’s September 6, 2013 not-approvable letter. “The purpose of the meeting was to present the agency with our proposed answers to questions raised by FDA in the September letter and to help clarify our final responses,” said Gene Cartwright, CEO of Guided Therapeutics. “The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA. We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days.” Once submitted, the FDA will have 180 days to respond to the company’s submission. Additional dialogue with FDA is expected as the company proceeds toward PMA approval.
GTHP announced May 14th they will refile with the FDA within 45 days. As a result, the deadline is Sunday, June 29th per their press release. To meet the deadline, GTHP will have to refile by this Friday, June 27th. Technically speaking, refiling on Monday, June 30th is one day late based on their press release. I am hoping to hear sooner rather than later about the refiling this week. This is an important hurdle for the company and I am eager to see the filing. I have to believe GC will do as promised and not be late. As the FDA clock start clicking the urgency to buy will increase. This is a deadline will really do not want to miss.
It seems the CEO is buying more shares. Large buyer with bids of 25K shares all day yesterday. Last week GC bought @25K shares 4 out of 5 days. It seems to me that the buying continued Monday. In a matter of fact it seems the buying from the CEO accelerated to 50K yesterday? We are seeing plenty of supply which leads to me believe that Cartwright is buying from Dr. Hart. Interested to see insider transactions at the end of the week.
Let see if we can manage to trade above 50 cents this week and hold that psychological level. Refiling on time will not hurt and reenforced that the the new GTHP does not over promise and under delivers.
I am thinking that Gene Cartwright is buying more shares. I also think Dr. Hart is selling shares today. I could be wrong but I think Gene is buying Dr. Hart shares at 49.5 cents. We will know later this week. The way the stock is trading it has that feel. Cartwright versus Hart :-)??????
I think mid August (EPS report) is the first opportunity at a significant shift in the stock. With Gene Cartwright buying stock, it is hard to believe the stock can move down much further. If GTHP can show sales north of $500K and more importantly increase the 2014 forecast, people will be force to start buying ahead of FDA. At the present time, there is no urgency to buy. Once again, we need to get this FDA refiling done in June.
Ooops....Sorry not my first language.... Not even my second. Some things about your language I will never understand. For example, it is ON Tuesday but it is in IN July? How weird.
Gene S. Cartwright, Ph.D. For 33,358,541
Non Votes 26,705,732
Ronald W. Hart, Ph.D. For 20,940,509
Non Votes 26,705,732
John E. Imhoff, M.D. For 23,600,286
Non Votes 26,705,732
Big seller at 49 cents. All I can think is Dr Hart selling another tranche. Did you see how many people voted against him? Obviously, some insiders voted against Dr. Hart. Interesting.
Volume is great but we had a lot of sellers @ 49 cents this AM. People are selling at prices where the CEO was accumulating? Maybe Dr. Hart is using Cartwright buying as an opportunity to sale another tranche? I wish the stock would trade above 50 cents. The CEO is doing what I wanted. So no complaints here.... Let's get this refiling out of the way!
This week I want to see the company refiling with the FDA. Technically speaking 45 days from the May 14 announcement translates to June 29 (Sunday). I just want this hurdle out of the way so the clock can start clicking towards approval. I hoping this week versus next week (Monday, June 30th). I am going to assume they will refile as promised May 14th. Anyhow, that is what I am watching. I do not understand sellers at these levels with the CEO buying.
I really do not understand people selling at these levels with the CEO showing this level of commitment. Looking forward to the refiling to start the FDA clock. Hopefully by next Friday.
"I do know that they are unusually busy of late and its not for the purpose of putting out fires."
Based on your inside information do you feel GTHP can easily achieve the mid point of the sales forecast for Q2 of $500k? It seems you are comfortable with sales exceeding current estimate especially on the second half. Maybe we need a blow out quarter (sales) and a sales guidance increase for people to notice. I would like to see GTHP trading closer to $1 before FDA. That would be a nice set-up before approval.
I am surprised by the price action today. The CEO is buying, and we received great news about Luviva a couple weeks ago, but the stock is stuck at 47-48 cents. Puzzling to me. The CEO buys stock at 49 cents and people are willing to sale at 47 cents? Really? I am encouraged by the the ACTIONS conducted by Gene Cartwright as well. FDA refilling should be completed next week too, so the FDA clock will finally start clicking. The next hurdle is @ mid August with the EPS report. The estimate is $200k to $800k in sales. Anything above the mid point would be very encouraging to me. More importantly, if they can fine tune the 2014 forecast raising the lower portion of the estimate ($1mm-$3mm) will the market continue to ignore GTHP until we get FDA approval early next year? I think the stock is cheap and with the CEO tipping his hat to the market it warrants a higher stock price. Again puzzling.
This is awesome news! Finally. Very encouraging. I know the amount is very small but this is the best news from GTHP in a long time. Volume has also increased lately. Volume ahead of price. We are hitting resistance at 49-49.5 cents. Next week GTHP should refile with FDA. Maybe we are finally moving forward. Very positive. Now I can finally shut up about insiders selling and not buying in the open market. Thx for the post.
You are probably correct. Sea, he misled people. His pink colored glasses forecasts were complete lunacy and he really hurt the company. I can not get over his tenure as CEO. He almost killed the company. My dead grandmother would be a better choice as CEO than Mark. He was beyond awful. His "forecasts" were complete FRAUD.