Unfortunately for me Kayak, I downsized my ELTP, and only have a small position left. Most of that profit went to CTSO. Good luck with ELTP. MDLAND~
Some might say we took a a big hit yesterday, and try and bash all day long. Let's be realistic though, our base was $.08, though someone bought on the rumor of the news to push it to $.09. In actuality, we've only dropped two cents in price, nothing to panic over. Most of those sellers were probably fools from Team Iggy, or those that didn't do thier DD, and thought there would be approval this month when Jim clearly said this summer. Now that the shake is over, we'll be back to $.08 by week's end and waiting for AMIC's next approach. MDLAND~
One thing is for sure, if we somehow get approved as a Class III device before summer's end, that would bode extremely, extremely, well for AMIC, as we would have exclusivity to a very unique and potentially life saving practice. As we all know though, the hurdles are there, and now the challenges begin. Again though, that's why at the present time, the pps is at $.09 and not $.90. Everyone, including the dozens who don't participate here, and the medical community at large, is waiting for validation of our product from the FDA. Since a large percentage of FDA applications don't make it past the first step, we are seen by many, on the outside, as just another company with a dream. Some will say that we have now made it past the first step, others will argue that we are still at square one. It will be interesting though, to see how investors react in the next few trading sessions to the most recent FDA response.
I guess for now, if you believe, it's a good opportunity to load up. If you don't, move on and try a mutual fund. MDLAND~
Yes Kayak, looks like we're in for a longer ride than first anticipated. I don't know how they expected an implanted nuclear device, . . . okay, maybe that's a slight exaggeration, but anyhow, the expectation to pass as a Class II device was ludicrous. Now we do need more time and more money. Now it looks like either outside support or dilution may be AMIC's next option. Hopefully the fact that the FDA did not deny AMIC will inspire some to support us via share purchase, grants or partnership. MDLAND~
Medplay01, I agree. The fact that it wasn't denied is seen as a positive. Not just by (some of) us, but by potential investors and the medical community. Hopefully we can start to get some more 'quiet accumulation'. Again, to expect a walk through, in the FDA process of approving a Class III device by a micro cap like AMIC would be unheard of. Again, we're not trying invent a new bandaid, this process is going to take at least one, if not two more steps. Perhaps now, folks are starting to believe, and we can get some financial backing, i.e., grants or investment partners. MDLAND~
The fact that our device is considered as Class III was expected, but that also means a bigger hill to climb for regulatory approval. Hence, the reason AMIC wants to reclassify as Class II. Good luck with that though. This device isn't exactly an inert device made of glass, wood and steel. Class III approval is much more stringent, detailed, and as a result, more costly than Class I or II approval. We could be in for more wait time folks. MDLAND~
This statement near the end of the P.R. is interesting. Possible future, Merger? Takeover? Buyout?
"The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans". Kind of an 'open' statement, though not interpreted by me as negative. MDLAND~
An 'intermediate' response from the FDA. Out of the three classes of medical devices, I think it was pretty obvious that if anything, it would be considered a class III. Class I would be a bandage or splint, Class II would a wheelchair or stretcher for example. Class III would be like a pacemaker or stint type devices, etc. Because of the invasiveness and life altering potential of AMIC's product, it could be only classified as a Class III device. I see this as a big step forward. Remember anything other than a denial by FDA is seen as a positive. I am taking the glass half full point of view. To see our product fly unimpeded through the FDA process was being too optimistic. I think the FDA likes what it sees, and likes the potential that the product has, but it also wants AMIC, like everyone else, to go through the necessary, regulatory process. Again what may be perceived as common or ordinary news to some, is perceived as good, and expected news by others. You can bash or acknowledge and appreciate. MDLAND~
Guys, I think the initial expectation was sometime in February 2014, and to try and predict when and what the FDA will say, was a mistake on AMIC's part. As a result, shareholders who have invested their money (and in the case of half of us, due diligence), have this optimistic time frame as well. I think that once Jim realized that the FDA runs on it's own schedule and that AMIC isn't on it's high priority list, he pushed the date out to a more general time period of, ''by this summer''. Moral of this story for all of us, including AMIC is, FDA will do what it wants to do, when it gets around to it. Whether it be 90 days, 90 business days, 90 days including leap year and holidays, the U.S. Gov't runs on it's own schedule. MDLAND~
8K is usually filed within a few business days for events "deemed material" to shareholders. Of course this is a gray area and can be interpreted differently. Now if this were bankruptcy, or a change in directors, that would be, cut and dry, and would definitely require an 8K within 4 days. Again, we aren't privy to the daily events of AMIC. If that were the case, we'd have a P.R. every time Jim got a phone call. Personally, I could do without the, unnecessary, 'fluff' P.R.s. Just the facts ma'am! MDLAND~
SS, my thought is that the FDA asked for more information or something more specific from AMIC. Again, any news release implying a delay could be perceived as negative, and could hurt the share price and shareholder confidence. As a result, a decision may have been made to communicate with the FDA without notifying the public. Remember, every single detail about the ongoing approval process doesn't make the headlines. MDLAND~
If you are waiting for FDA to respond in February as was the initial plan according to Mr. Katzaroff's statements last year, you will be frustrated thru February 28th. If you are waiting for positive FDA response by mid-year as stated in Mr. Katzaroff's later speech, you won't be looking at the stock price everyday waiting for FDA news daily.
I will admit though, by mid summer, I too will become a little nervous. Keep in mind, not all FDA responses make the headlines. The FDA could have asked for more information during the period of January and we would never know. The date did get moved for one reason or another, we just don't know why. MDLAND~
If you truly have that many shares and are willing to invest that much more into CTSO, you might not want to ask the opinions of members of a message board. MDLAND~
I see that we have some director filings that have hit the news. Looks like they were for the end of last year. I'll look them up when I get to work. MDLAND~
SS, what does the "C" stand for in, James C. Katzaroff? MDLAND~
SS, There is a chance that we may see $.08. A lot of that depends on timing of FDA updates and/or other positive news. If AMIC is dormant with regards to updates, and FDA doesn't respond in the near future, price could easily drift downward. I think that AMIC is selling into the volume and price to fund the business, which is understandable short term. After a while though shareholders are going to want to see the fruits of their investments. JMHO MDLAND~
They gave Denver a beat down. Good win for the Pacific North West.
There's another team who is looking for a win up there in that region, it's name is, Advanced Medical Isotope Corporation. Hope to see more consolidation and rise in share price this week. MDLAND ~