This will be in a very different place in next 90 days.
1 - company has had a very good conference
2 - Listing is imminent. paperwork / process etc. This week or next I am led to believe
3 - Company Execs even more bullish than usual. Something more and new is afoot. Don't know specifics (yet)
4 - I am anticipating very impressive news re ASCO
5 - Good meetings scheduled at ASCO
6 - India will be first with deal ahead of China. That's my take.
7 - More activity with India. Not unreasonable to assume Pfizer Indian guy on advisory board is heavily involved
8 - As we already know more progress soon re other designations. Liver an breast
9 - Broader and growing acceptance by big Pharma that local therapy is a viable, effective and applicable approach
10 - And of course there's that matter of BTD for MM for a wider label
11 - I am sure there is more ...
IMO this is a major buy at these levels. Very little downside with a huge upside.
ONE of the many reasons you are a HACK is that you cherrypick your facts only to support your own opinions. Either you're immature and juvenile and don't know how to write, or you have no ethics and only serve to feed your own pre formed opinions. This is why you are not a writer, but an entertainer. This is why you are not a scientist, but a political scientist major.
Did you DIRECTLY ask Dr. Weber about PV-10? Because the snippet you took from his email does not mention PV-10, but intralesional therapies, in general.
In the past, Weber had given a talk about intralesional therapies, saying they are just not enough, and he purposely left PV-10 out of the conversation. Why? Because PV-10 is NOT intralesional. It is BOTH systemic and intralesional, which he discussed and had on his abstract, explaining the immune response shown in patients - some of which responded to none of the current available checkpoint inhibitors available, and yet responded extremely well to PV-10.
Why not quote Dr. Weber in context?
Like this quote of his:
Moffitt's Dr. Jeffrey Weber, M.D., Ph.D. said “This data provides more and more evidence that you are altering both local and systemic immunity in a positive way. It also provides a rationale for combination trials of PV-10 with check point protein inhibitors, such as ipilimumab, pembrolizumab and nivolumab. PV-10 might offer the perfect way to prime the immune system”.
Gsmort3 - are you aware of many (or any) small cap tech companies that have demonstrated 10 (ten) sequential growth in mobile and security? Last qtr in excess of $5M in M&S and all in a MRR model? So this is what ETAK has achieved. You call it a "crack pipe". Please share examples of other small cap tech companies that have 10 (ten) SEQUENTIAL quarters of MRR growth.
Do not disagree. I have read the FDA BTD rejection letter countless times. It seems unusually almost in two camps. There is some strong language for PV-10. There is the request for more data. It does not appear in anyway that the FDA is dismissive of PV-10. This alone is encouraging I feel
2 of 2
Yes, intralesional therapies should be used in conjunction with checkpoint inhibitors, to attack a systemic disease like melanoma in two ways - with your immune system and locally.
PV-10 does BOTH of these things, and does them very, very well. Very, very safely, and much, much cheaper.
Obsolete? No. In fact, PV-10 is the next stage of development for local cancer treatments as it is the first and only known so far to provide both systemic and local therapy to treat melanoma, with a 50% COMPLETE response rate, which is astounding. And it has no negative side effects triggering autoimmune diseases.
You either believe what you write and are sad...or you do not believe it, but instead you do it for entertainment, like Bill O'Riley. The sad thing is, people take your entertainment as "news", whcih it is not.
Mike you are a short - part of the orchestrated short team. Good like to you if you succeed in managing to scare weaker hands. Personally I have a boat load of shares and have ben long for 5 years plus. Still holding baby. Your referred article does NOT refer to ANY of the following (and these are just some of the observations):
1. Compassionate program for PV-10 has been FDA approved and in place for YEARS
2. Compassionate program for PV-10 was allowed to DOUBLE THE DOSE at the approval of the FDA
(so we already see that the FDA does to some degree believe in the drug)
3. Is the author of the article more qualified than Professor Thompson, Dr Merrick Ross, Dr Agarwala, all the participating PhD's at Moffitt center etc? Really?
4. Moffitt Data re PV-10. Moffiitt PhD researcher quote "have not seen anything like this in 40 years" - that is FORTY YEARS
5. Moffitt - INDEPENDENTLY - working on combo of PV-10 with other big pharma cancer drugs - improving efficacy MATERIALLY. Even you understand that term you scare mongerer.
6. Even the article stated PV-10 made it to the end of phase 2. Who do you think approves that? Well that would be the FDA you low life
7. Company execs - yes yes there are only 4 employees (amazing inventors aren't they ?) have been exercising their options left and right. Of course they would do this because ???
8. Weider MM label. That was at the behest of the FDA.
9. And we are awaiting BTD application outcome. Company is due to receive this from the FDA no later than Friday this week. Company has to publish 8K update within 3 business days.
10. So much more ....
SEE MY CONTINUATION
revenue growth is excellent. Great business model. MRR. The only issue is balance sheet which will get resolved IMO. Which will be superseded when cash flow positive ...which is imminent.
buyers like me are buying cheap gifts from shorts or scared sellers. Thank you. Word to the wise. Keep you cool. Read Wachter's comments carefully on the recent call. Despite AF saying that "dealign with symptoms does not qualify for approval" the FDA told the company in December 2013 "We like this ablative effect that you're showing in patients with disease confined to the skin. But can you show us that also IMPROVES SYMPTOMS that we heard are important in melanoma: pain, bleeding, infection for example. AND THAT WOULD BE A WINNING COMBINATION"
Furthermore, I actually believe the company wrt India & China deals brewing. And that these deal do not require FDA BTD approval. We may receive an update in the not too distant future. This will, if a deal closes, help solidify the balance sheet. One of my fears, to be brutally honest, is that a non American entity offers the company enough money and boom patients will be at the behest of a European, Chinese (or other) entity.
I imagine it unlikely that the FDA would leave it to the 11th hour (we are in day 59) to deny BTD application. I would imagine FDA is deliberating with respect to guidance / pathway for NDA....
You forgot to mention all this stuff huh? Yet you know all of this and more.
You make your living being part of orchestrated short teams (and more of us are getting to know who you guys are). Good luck to you. But to achieve your goals by misrepresenting and trying to scare people? You and your team will receive a well earned visit from an entity way more important and powerful than wealth.
Enjoy your visit from Karma when you get it and boy you surely will ......
I thought in the comments section of his useless short attack article. He tried to engage in a question or two but seemingly and easily outplayed. SA is a trash pub. Should not allow ananymous groups to publish and should at least do some vetting.
GBA (God Bless America) the land of entrepreneurs and inventors. This is why USA boasts so many early stage biopharma companies. Those that can, invent and get stuff approved that big pharma can only get by means of acquisition or licensing.
read Erich Wacter's comments from con call as transcribed in Ross's article on SA. I found it incredibly useful. My takeaway is the the FDA and PVCT have good and detailed communication in a positive spirit.