My question would be is joe_pinto1999 honest or not? A review of his posts indicate that nothing about PVCT has merit...... so Joe, you got sumpin else to do?
What kind of idiot does it take to short into a short covering rally????? As of 5/15 there were still over 5 million shares short. Couple that with an approved drug being rolled out to the marketplace soon..... this company's share price has been held down too long by traders and shorts...... time to rock and roll.
I think most folks can figure out by now that AF has a narcissistic complex..... anyone who is so fixated in sticking to his rants instead of letting the situation play out has problems. I think he really believes he is trying to save us. Most of us understand what PVCT is and the risk/reward of companies like this.....having said that all testing done by competent medical professionals fly in the face of what AF insinuates. Time for tune out..... AF and ambulance chasers.
We all know what a great job government agencies do.... no bureaucracy, always straight forward and accurate, no politics involved, very efficient, always competent; therefore,IT IS ALL PVCT'S FAULT. If we knew the real facts we may have a different point of view. PVCT can not defend themselves here...to do so would risk the rath of a governmental agency who holds all of the cards. If you listened to the CC you got the feeling that they were shooting at a moving target in dealing with the agency...... I think part of the problem was that the agency was not familiar with a drug like PV10 and needed to know how it worked which took a long time. I think everyone can agree that if the tumor was gone that the chance of bleeding, infection and pain would be much less important end points..... but, if it was clear to PVCT it was a clear omission..... without all of the facts, judgement should be reserved.
They have $19 million in the bank, they will announce steps forward after June 2 ASCO, they have already hired a firm to assist with communication with FDA, in spite of the back biting here PVCT continues to partner with quality Doctors and hospitals..... THEY NEED TO DO A SERIOUS MANAGEMENT ACCESSMENT TO DETERMINE WHO MAY HAVE MADE BAD DECISIONS AND WHO IS TO LEAD THEM IN THE FUTURE.... PV10 works and that is what will drive the future of the company....
Medium-term lurker here, 1st time poster. I'm an oncologist, but I haven't worked on any of the PV-10 studies. Feel the need to post now because I get the sense that most of the posters are misreading the FDA letter and what they're actually trying to say.
The FDA letter is NOT bipolar or contradictory. There is no disagreement among anyone (FDA, shareholders, mgt, oncologists) about substantial tumor and bystander response to PV-10 injections, hence the FDA acknowledgement of "reduction in the size of one to 10 target lesions...".
In fact, the FDA explains exactly what they meant by "the preliminary clinical data do not demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints" in the very next sentence of the letter (which unfortunately never seems to be quoted): "This determination is based on the paucity of data on endpoints indicative of clinical benefit (e.g., pain, infection, significant bleeding)".
I.e. the FDA is saying that the application did not have sufficient data on pain, infection, bleeding in response to PV-10 injections to demonstrate a clinically (i.e. statistically) significant response. In hindsight, this is fairly obvious since this data would've had to be collected at multiple time points during the Phase 2 study, and nobody involved was thinking about symptom control as the approval pathway at that time.
Basically, the FDA is saying that PVCT hasn't collected enough data to demonstrate "symptom relief", which is the indication they are applying for. Tumor shrinkage, bystander response, etc. does not equal symptom relief. Any bridging study or PIII study would need to prospectively measure symptom scores with objective, validated metrics and demonstrate a significant decrease after PV-10 injection, and show that this decrease is durable over a reasonable follow-up period. This type of study should be relatively short and simple to complete, and the FDA still is not requesting survival data
Are you guys nuts?????? Lining up with some #$%$ bag to rob companies funds...... end analysis, shareholders get $1 and the attorneys get millions. This is a speculative stock..... if you can not stand the heat, get out of the fire!
Management is fully vested in the success of PV10......it is obvious that they have a lot more experience with FDA now....it was clear in the Conference Call that they see a fairly clear way forward. Some of the end points that the FDA wanted were not measured in the Phase II data....pain, bleeding, etc..... remember that on June 2 data will be presented on patients that had undergone extensive treatment for their melanoma and did not get a good response; however, when treated with PV10 the response was very very good. I continue to be long on PVCT..... patience is needed here.
With the results PVCT has been getting with PV10 in even more recent applications..... more data will confirm the advantage this drug has over existing drugs...... even give time to examine how PV10 works in concert with other drugs. Unfortunately, approving drugs in the US is a long drawn out and expensive procedure. I saw one post that suggested that maybe PV10 could be approved for use in another part of the world before approval in US.
I am disappointed, but still a believer.
In view of the ambulance chasers entering the frey....PVCT probably has to be careful how they scribe a PR....hopefully, this will be the day we have been awaiting!
A disgrace to the legal community
The shorters can only short if they own shares or can find shares to borrow and pay brokerages for the transaction..... contact your broker and tell them you do not want your shares loaned out to others.
Whether the Breakthrough approval comes through or not...the product has not changed and is truly a fantastic drug. Time, not today, will prove that PV10 will save lives and make investors rich.