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I read an article today about share structures and after reading the article I have come to the conclusion that the new preferred shares that were created by the SEC filing on June 30th were done for a new prospective partner.
A new partner coming in at this point would want some assurances that if they are going to pump in some more money that they would get beneficial treatment if there was a failure in the future. Their shares would get beneficial treatment.
We will find out soon.
Here is a link to the article:
http://venturebeat.com/2010/08/16/beware-the-trappings-of-liquidation-preference/
No need to alert us. They will have to file with the SEC. It only shows a lack of knowledge by stating that somehow the James will just start printing shares.
They will have to file with the SEC first if there will be substantive dilution. They are at or near the limit of authorized shares.
I think as soon as they file the 10-Q (next Thursday?) we will get news.
Google and Apple spend more annually on patent license fees than they do on R&D.
You should really read a little before posting.
AMIC filed its de novo submission in December of 2014.
FDA launched the EAP program in April of 2015.
So how do you think that the FDA could have recommended AMIC to use a program that did not exist when they submitted?
Was I correct about the quiet period? I may have to send James another email and confirm.
Apparently you have never worked in a government job. It is very typical to draft letters and have them not hit the mail for at least a week.
I remember letters that I drafted and they sat in a basket for a week before they finally got signed and then sat again for another week because someone who was suppose to prepare the certified mail was on vacation.
Good for you. I don't really care too much about the front cover page though. I expect as most government agencies the wording is 99% the same on all rejection letters. I would be more interested in trying to glean something out of the redacted pages unless they are 100% redacted. That's where the nuts and bolts are and you could get some type of idea as to what type of hurdles they may have remaining. Or if there is any wording about follow-up submittals.
End the dilution talk now. You can easily see from SEC filings that in the past when shares needed to be increase AMIC would file a proxy statement requiring a vote by shareholders to increase the authorized shares. No such proxy statement has been filed as of yet.
Past proxy statements have provided about a 3 week lead time on the vote for authorized share increase.
So, no proxy statement filing, no immanent vote, no authorized share increase, no immanent dilution.
End of story.
I thought the comment about the secretary was laughable. I work at a large private non-profit research institute (hmmm, wonder which one?) and we have gotten rid of most all secretarial jobs long ago. Everyone has a voicemail system to save money.
And yes, I have spoken to Mr. Katzaroff recently and only got the best impressions from our conversations.
With that rationale, if you believe people have heard about the dilution then there should be high volume because people would be selling to get out before their stock price dropped.
So you say he should have been better prepared, but then you follow that with saying that you don't know how many animal studies were done.
Perhaps it would not have mattered if he would have spent another year doing more animal studies and that he needed to get the application filed to get the FDA to focus in on where they wanted more data.
He may have done exactly what needed to be done. It is very possible that even if they did 2 or 3 more animal studies the FDA still would have said they needed to do one more. I have seen this type of response from the NRC. No matter how well you have a license prepared, some reviewers will still come back with questions (sometimes meaningless) just for the sake of having questions. It all depends on who you draw as a reviewer and I know the FDA has a lot of new people in this section. More apt to send you back for more info that approve outright.
I don't think it matters. If news would have come out during the day the stock would not have slid down slowly; it would have gapped down hard and there would have been no time to save money or fill orders.
There is a way to raise capital without dilution. I have seen mining companies do it before. A cash infusion for a percentage of sales down the line with no stock transactions involved.
They could sign an agreement now for distribution of RadioGel with an agreement for a percentage of sales down the line with an immediate infusion of cash and no stock.
Did you ever get a reply?
Battelle is not in the business of taking products to market. They are in the business of improving products such as they did for Xerox so that technology could go to market.
I am not familiar with the timeline of when the "first company" gave up. If it was before the time period when therespheres and microspheres have been approved it makes sense that now that there is already something similar that has been approved by the FDA that it opens up the door for RadioGel to be approved.
I have wondered about the possibility of a reverse takeover with one of the new private companies doing the Mo-99/Tc-99m work. Several of these companies have received millions in DOE funding and some are also doing FDA proposals.
NorthStar Medical Radioisotopes
SHINE Medical Technologies
Coqui RadioPharmaceuticals Corp
just to name a few
Okay, I'll try one more time. Many times even LLCs are not completely shielded. Many times you are required to sign a personal guarantee for loans while operating an LLC. A great majority of personal bankruptcies are tied directly to business failures.
http://www.bayareabankruptcylawyerblog.com/bankruptcy-in-general/why-small-business-failures-so-often-trigger-a-personal-bankruptcy/
9 out 10 start-ups fail. So if you are in the business of start-ups you are more than likely going to have a bankruptcy somewhere on your resume. It is just a fact.
http://www.forbes.com/sites/neilpatel/2015/01/16/90-of-startups-will-fail-heres-what-you-need-to-know-about-the-10/
And of course The Donald has had four companies that declared bankruptcy.
The news on the notes was a required SEC filing. I don't consider that PR....and as I had posted this is a quiet period. Is it possible that they will have to wait until ~8/14 before any actual PR does come out. I don't know how they have handled quiet periods before.
Quiet Period - How has AMIC handled the quiet period from end of quarter to filing in August in the past? I saw there was no news release during this period last year. It may be that they will release no news until August report.
I have not been in this stock very long so just wondering from past experience how they handle the quiet period.
I probably only needs to go through their own IRB, but I can check on that.
I encourage all of you to do a little homework this week. I have a very large university veterinary hospital near me. Best of all it is also a teaching hospital so student vets who use new techniques and devices bring that knowledge with them to their new practices when they graduate.
I have already passed on the contact info to Jim and I am now going to go through my contacts with the university to see if I can find someone who knows one of the Radiation Oncologists so make them personally aware of the existence of RadioGel. They already are doing a lot of pet and large animal (horses and zoo animals) cancer treatments at their facility.
Nothing like a little "self" promotion. I own it, I could just as well promote it myself. If you have a university veterinary program near you, I encourage you to do the same.
Fair Winds and Following Seas
Exactly! The article I posted showed that some people are willing to pay between 2-10K for chemo for their dogs leukemia. I think Radiogel may be a much less expensive alternative for many organ cancer treatments.
$50-100 million sales range potential
"Obviously, owner out-of-pocket costs limit the potential of pet therapies to achieve billion-dollar projections as in human cancer, but it is not unreasonable to assume novel pet cancer drugs could eventually generate sales in the $50m-$100m range"
Very disjointed market, but expect growth:
https://www.agra-net.net/agra/animal-pharm/analysis/pet-cancer-treatment-rd-dead-end-or-the-next-blockbuster-goldmine-478987.htm
There is only one that matters right now in my opinion and that is the protocol that the FDA will specify. Any work that is ongoing involving grants may be helpful, but is not specific to what the FDA has now requested.
60-day animal study
We can turn an animal study around in about 60 days and with this type of material I expect that is what they will have to do. Because of the shorter half-life I expect however they want the animals dosed, analysis of samples will not begin to occur any later than 5-7 days post dose. Any longer time periods and your dose needs to be doubled in order to meet your detection limits.
The material is essentially decayed to nothing within 25 days of dosing so you need to be quick and efficient in your methods. I expect the study needs to show that where the gel is placed is where the gel remains over time and you cannot detect it in any other part of the body...show that it does not migrate.
If they were to meet and agree with the FDA on the protocol early in the 4th quarter....say October then conceivably you could have the study completed by end of year and be resubmitting in January. That is about the fastest timeline I see.
I don't know if you noticed, but the company that filed suit against AMIC filed suit against another company on the same day and I believe 3 other companies in just the same week. To me that made the suit look frivolous immediately.
Not cool at all. To me it just shows that information is always leaked and the last people to find out are the small investors.
ADMD after hours news. You really should have included in your commentary that there was after market news release for ADMD. FDA did not grant them approval, but wants additional animal testing performed prior to new submission. This will greatly affect the price pattern for today regardless of technical.
More animal studies? Really? I think they got screwed by the FDA. When the delivery method has already been proven safe and the radionuclide is already in use what gives? This pushes it out probably at least another year and by that time a larger company with fatter wallet will probably have the same if not similar product on the way.
I will hold, but my confidence in the FDA just went down. Maybe I should have taken that job with the FDA as a device reviewer.
ADMD's first no took around 90 days I believe.
Yes it does. We just saw yesterday how the average time for approval for the FDA has gotten better from almost 900 days a few years back to around 300 days in 2014.
FDA De Novo process
This is a pretty good article if you are interested in the De Novo process and how it works:
http://www.meddeviceonline.com/doc/secrets-of-the-de-novo-pathway-part-why-aren-t-more-device-makers-using-it-0001