I'm wondering how "new" this information really is, and what impact it may realistically have in the next few days. My first thought was, not much. They "instructed..." - meaning the submission still isn't done. Not the progress we were looking for.
But then "Battelle" is going to do Six submissions! I don't think Battelle would sign up for this task if they didn't think the chances of success is high. And if they're wrong, they're not likely to be wrong Six times. So I take Battelles' role X Six application = Very High - 90+% chance of at least one approval by the USDA.
And I believe other posts indicate this should be 3 - 6 months, with a reasonable chance of being faster, give lower end of the risk spectrum, third-party data, and Bettelle's experience at the submission process.
I look forward to thoughts on this analysis, and how valuable this information is, v. what we've known up till today.
Pharmasset sold for $137.00 a share while in the third phase of their trial for an HIVC product that has a $4 billion dollar market. They had also lost $91 million dollars their previous quarter.
Nanoloogix supposedly has a market potential of $50 billion dollars or more.
I personally do not see a lot of production in the future of Nanologix.
If a reputable company, Arnold & Porter, puts together a financial market value and then seeks out their competitors to gauge what interest they have in purchasing Nanologix, then this could get very interesting very soon.
I also believe it is Nanologix duty to do this and to have the necessary funds in reserve to operate this company for the next 12-24 months.
Pharmasset is a real company ........ sold for $11 billion dollars!
If Nanologix sells for approximately $1.2 billion dollars = $10.00 a share
You can do the math from there.
We are trading at .375 a share.
For those of you who are waiting to buy more shares later ...... good luck.
I do keep adding to my total but they are all for fun now.
Who knows ..... are you prepared? :)
Great post Warfield!!!
And for anyone out there thinking of phoning Battelle, to pester them for information on the submittals--------------DON'T.
No use getting Batelle PO'd at Nanologix. They are the goose that is about to lay the golden egg for us all.
Looks like I might be answering my own question. From the FDA website:
"Please Note: If the person who intends to market the device uses a consultant or another party to prepare the 510(k), the 510(k) submission should specify who the 510(k) owner is and who the preparer is. The 510(k) owner is the individual or firm that has legal authority to the device."
I think Battelles reputation is strong enough that there is no question it is an advantage for NNLX that Battelle will handle the submission.
But we already knew that Battelle and NNLX had a partnership. It this a positive surprise, that Battelle is doing the submission, or not a surprise?
Is it a surprise that there will be 6 submissions by Battelle on behalf of NNLX, or is that not a surprise?
If no surprise, then no big bump. Just a bit of confidence-building to stop the decline until we get an answer from FDA.
Is it a positive surprise? Is a bump indicated? Or is it damage control, just a slowing of the downward trend? (Until FDA approval and sales, the REAL news that is needed?).
I need a little help to understand something. I have some modest experience in the 510k approval process, but I make no great claims of insight. In the late 90's as VP Marketing for a fiberoptics lighting company, I also headed up the medical device group, including the engineers. I oversaw various certifications, along with some FDA submissions. We submitted applications on behalf of ourselves. I believe the submissions also included manufacturing processes (but I could be wrong) and also included heat testing.
Could someone explain to me how one body applies for FDA approval on behalf of another body. The second body is the manufacturing, seller and patent holder. Exactly what vested interest does the first body (Battelle) have that allows them to submit? Could someone please clarify.
I too have no knowledge, but this is my guess. Like patents, 510k approvals are done by a government agency and must be in a very strict form and content in order to get approval. I am guessing that a company like nanologix would probably mess this up on their own, whereas Battelle knows what is going on, much like a patent law firm and can organize and submit these things correctly the first time, thus saving money and time in the long run for Nanologix.
dhw, my guess would be your best bet at an answer would be to ask the FDA that question. Don't ask about any specific companies just as a general question and see what kind of reply you get.
I have asked them a question before and they were very helpful.