Obviously, the bulls are betting we receive FDA approval of Luviva in 2014. I am eagerly waiting EPS news to get more info related to the FDA submission. I believe the company is changing their approach how to get approval for Luviva. Excuse my ignorance, but my very basic understanding is that GTHP can try to receive FDA approval as a screening tool versus a triage tool. Will that satisfy the FDA's questions and allow for units to be sold in USA? I am betting approval in the US and ramp up of international sales will result in GTHP trading @$1.50. For patient investors I believe GTHP can easily be worth north of $5 in a couple years. Of course, Nasdaq listing will be require to achieve that price per share and we are not talking 2014 either. Does anyone have more info about the FDA response/submission? I wish we could get better info on this company. I do not even know when they report earnings (losses, really....).
Regarding earnings. I think that they will have sales that were reflected in both Canada and Turkey. I'm not looking for gang busters.
About the FDA. GTHP is as stated by gpost expending much effort in order to have a face to face with the FDA. It is a priority and one that management puts a lot of faith in as a way to help further Luviva along in the process.
What I am led to understand that GTHP is asking for about using Luviva is to be used as the secondary step to a colposcopy. Currently if through a pap smear, it's determined that something looks peculiar, the next test conducted is a colposcopy. It's where they surgically take a biopsy from the cervix.
The sad part about the colposcopy's is that 40% of those conducted show no abnormalities. (False Positives).
GTHP hopes to be that secondary test to the colposcopy which is very expensive and traumatic. I personally think that in time they could be the first line of defense, but that's more my optimism.
I hope you are correct about Turkey. I was expecting the Turkey order to ship prior to Sept 30th. I believe they are having a software issues with the units. To be honest, I am not sure what the issue is. GTHP fault or a specific customer request that they are working on? Anyhow, add the economic meltdown in Turkey and the delay makes me nervous.
Personally, I believe one of the reason a new CEO was hired was because of the lack of actual sales generated by Faupel. I would not expect any significant sales in Q4 which would explain the reason to remove Faupel from the CEO position.
I had expected that Faupel scheduled an FDA meeting in December.
Per my conversation with GC a couple of weeks go, scheduling a meeting with the FDA is one of his priorities (so Faupel had not done so).
He mentioned that he has previously been at the FDA for such meetings and seemed confident that all the information requested by the FDA is at hand.
I haven't followed up for an update.
There should be a CC soon.
Have you heard anything about completely changing / updating the FDA submission as a screening test versus a triage tool? Will that have a significant impact how FDA sees Luviva? Wouldn't it lower the FDA bar? I guess we will have to wait until the end of March to find out more about the progress with the FDA. My understanding is that they have NOT responded to the FDA yet? Can anyone confirm?