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Exactly!!!!!! BRILLIANT! !!
Glad to hear...outstanding!!
I remember my first clever post too!
Here is a link for what this means and a description for all app statuses. Look at table 9-1.
https://developer.apple.com/library/mac/documentation/LanguagesUtilities/Conceptual/iTunesConnect_Guide/10_ManagingYourApplications/ManagingYourApplications.html
Angry broke investor mad he cant find a way to break even. True story.
A man pretending to be a woman and XOXO'ing other men is a bad sign also. IMO
It means she has no idea....just means she knows how to copy and paste. Stop asking someone who is 0 for 30 for advice.
Looks like a board that's only for people that are butt hurt from Koos and invested money that they couldn't afford to lose.
Look at that new money shows up and the biggest crybabies on the board chase him away.
You have to be a level headed trader and realize the news from today is a recap with more details. We all knew there was another IND in the works already right? So given the fact that most already knew that (including big money that doesn't come to the board) the extra details in today's PR really means nothing to the trader. Social without taking this as a negative remember we already knew IND was coming soon. Even with the IND is submitted don't get over excited and expect a huge boom for long, example being when the last IND was submitted, it went up huge but at the end of the day it promised nothing. Keep your money patient and wait for Approvals... That's when you're going to want to party. The FDA will start the permanent party nothing else.
If that were to be the case a lot of people forget there may never actually be a "denial". So yes this could be swept under the rug eventually, the company has the right not to respond to the FDA and let this collect dust if it sees no future for whatever reason.
Funny how many faces should change their name to ECHO.... All they do is repeat s*** they heard somewhere else.
Yet have no knowledge of anything. Somebody sell this Eskimo some ice.
Actually it is.... that is what its called no other way around it
Should be one of these reasons found in 21 CFR 312.42
§ 312.42 Clinical holds and requests for
modification.
(a) General. A clinical hold is an order
issued by FDA to the sponsor to delay
a proposed clinical investigation or to
suspend an ongoing investigation. The
clinical hold order may apply to one or
more of the investigations covered by
an IND. When a proposed study is
placed on clinical hold, subjects may
not be given the investigational drug.
When an ongoing study is placed on
clinical hold, no new subjects may be
recruited to the study and placed on
the investigational drug; patients already in the study should be taken off therapy involving the investigational
drug unless specifically permitted by
FDA in the interest of patient safety.
(b) Grounds for imposition of clinical
hold—(1) Clinical hold of a Phase 1 study
under an IND. FDA may place a proposed or ongoing Phase 1 investigation on clinical hold if it finds that:
(i) Human subjects are or would be
exposed to an unreasonable and significant risk of illness or injury;
(ii) The clinical investigators named
in the IND are not qualified by reason
of their scientific training and experience to conduct the investigation described in the IND;
(iii) The investigator brochure is
misleading, erroneous, or materially
incomplete; or
(iv) The IND does not contain sufficient information required under
§312.23 to assess the risks to subjects of
the proposed studies.
(v) The IND is for the study of an investigational drug intended to treat a
life-threatening disease or condition
that affects both genders, and men or
women with reproductive potential
who have the disease or condition
being studied are excluded from eligibility because of a risk or potential
risk from use of the investigational
drug of reproductive toxicity (i.e., affecting reproductive organs) or developmental toxicity (i.e., affecting potential offspring). The phrase ‘‘women
with reproductive potential’’ does not
include pregnant women. For purposes
of this paragraph, ‘‘life-threatening illnesses or diseases’’ are defined as ‘‘diseases or conditions where the likelihood of death is high unless the course
of the disease is interrupted.’’ The clinical hold would not apply under this paragraph to clinical studies conducted:
No I did not miss that... I was simply saying when you doing one step more under exact match under advanced 24 hrs It returns nothing. Which is more relevant that all this original post meant was nothing.
And that the page source can confirm that for all.
There is no hit after Advanced search...
You have to drop your search term Down one box to exact phrase.
Clicking Advanced search Without doing anything and just clicking search does nothing then your previous search.
Like I said you can also view the page source and inspect the elements....Nothing
Don't want to burst any bubbles.... but if you go view the source by right clicking on the result and searching through the code you will see this leads nowhere.
For those that are familiar with similar/ cached results searching also comes up
empty.
An easier way if you don't know what you're looking at in the source.... go to Advanced search type in Hemaxellerate in the exact word match, Past 24 hours, so on and so on and returns nothing.
The algorithm Google uses can be based on many different calculations... especially when you narrow down your search...example time specific.(popular/previous searches)
Also try your other search engines does not return anything linked to FDA.
Correct but news of FDA approval would not need a meeting of the minds, a CEO would want to get the news out by any means necessary...example "IND approved more to come shortly".
Which leads me to believe the next PR will either be an update or the start of something new.
Too many people took rumor of a PR and translated it to an approval, which happens when someone insinuates that they know more than they really do. The approval will come when it comes.
Let me answer your real question...
No CEO would be dumb enough to share specific inside information about a PR with an investor. Why would he risk his entire career and possibly freedom?
Second you have to ask yourself wouldnt a PR regarding approval news have to be PR'd almost immediately. Even if the family dog was sick, family emergency, or illness of someone working with the company?
This should all lead you to believe that the next PR will be related to something else... Good news to follow just be patient on your own.
You also have to assume there's a delay every time they PR something...
It says they responded on May 20th but if you look back that information was not PR'd to the public until June 7th.
So it's hard to say where we really are Hopefully further ahead than we think.
May 20th Respond to FDA official comments....
June 21st Receive more questions for second round from FDA
July 31st today we learn about the June 21st happenings.... Good news is we should be about 40 days into the 2nd round
I agree with you...I don't need to voice my opinion on here or explain why but I call total BS also.
If the IND was put through another series/round of questions and responses they would NOT have to provide that information to the public immediately.
That would be nice and I hope so also, but be patient last time it took 2 months...
Its reported on Aplastic Anemia and MDS International Foundation as 600-900 a year in the US.
http://www.aamds.org/faq#t297n522
And another reports about 3 out of every 1 million people in the United States get aplastic anemia each year. The disease appears more often in eastern Asian countries, where it affects about 15 out of every 1 million people.
http://bethematch.org/Patient/Disease_and_Treatment/About_Your_Disease/Aplastic_Anemia/Aplastic_Anemia_(Severe).aspx
Exactly... there's no need to break down to each their own opinion. As far as the PR it is was referring to Q3 July-Sept.
Fiscal year = Financial year... Fiscal quarter = Financial quarter... its the basis for reporting financials, dividends, so on and so on, no more no less.
You never hear company say they are releasing new product during fiscal quarter......
I thought this horse was already beaten beyond recognition.
Actually it doesnt clearly say that at all. It says they will respond to FDA questions in regards to the IND hold in Q3.
The way I took this info from the day it came out was they will respond to the FDA IND hold by Q3 which means no later than Sept 30th but as early as July 1st. This means they will "RESPOND" to the FDA. Technically they could respond to the FDA on Sept 31st and still be in the time line. Nothing about the IND to be approved in Q3 or to hear anything from the FDA.
They will initiate trials in Q4 which means they are looking for the FDA to finally approve Q3 response to the IND in Q4 which would in turn allow trials to begin no later than Dec 31st but as early as Oct 1st. Again think of it as they could receive FDA approval Dec 30th and begin trials Dec 31st and still fall in the time line.
I am hoping for the best in all scenarios but you have to expect the worse as far as these time lines go and be patient. A lot of folks will bail if their own expectations are not met if they cant comprehend worse possible scenarios as far as dates are concerned.
How long did that last?
No not quite yet you would be able to see it on the clinical trial website. But soon hopefully!!
Call it what you want...made a lot of money here.
I did one this morning...1.25
I provided the post # but here you go...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83279394
He didnt reply to him this was copied from a January post #15047 and also from another forum in November 2012
Agreed
Reallllllly!!!! is that what its doing? None of us could figure that out on our own.
Yes... And I was 1 of the investors impatiently waiting for news but the last PR left two many questions to be answered. As others have stated also I kind of wish now they would have held out releasing anything until there was more solid information.
Also given the time line of events from the date BMSN released the 1st PR with the submission date of 2/5 it is my belief is either that...
A) The IND is did not pass with flying colors and is now on the "Next" set of 30 days review/hold. Waiting for responses from the company.
B) It did pass the initial 30 day hold but news is being released in bits and pieces.
C) There was a really backed up Mail Room at the FDA and they just confirmed receipt of the IND weeks after it was sent in.
Actually i am correct and so is my DD...even below on you last response now it says 30 days from receipt if FDA, which is exactly what I said
Your 1st post which i corrected you on said 30 days from when the sponsor receives the acknowledgement response from the FDA.
This is the incorrect info copied from your 1st post "once the sponsor receive the FDA acknowledgement letter with the IND number then the 30 days starts....."
I have to disagree with the 30 days...The 30 day review clock is based upon receipt in the FDA. Not the when the sponsor receives the acknowledgment letter from the FDA.
If this is a dollar by summer time i will retire 15 years early
And the other 50% wasnt...