Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Yeah but did he forgot that shareholders were expecting a APPROVAL ?
Can't he elaborate the details??
BMSN went from .0025 to .016 based on only one thing FDA IND approval. I still fail to understand why didn't Dr. Koos released a detailed PR about the entire process citing details like FDA receipt date, IND number assigned date, queries / discrepancies FDA asked etc...
As much as I love to hear the IND approval soon, I hate this CEO as well for following reasons
1) He is not organised
2) He don't respond to emails....I sent him so far 10-15 emails...and got ZERO replies
3) He delayed 10K past due date
4) Now when NOT NEEDED he release a PR which created doubts on approval process.
5) Why he has to declare 10Q on time today when everything was NEGATIVE????
Dr. Koos if you are reading this message I want to tell you this:
If I meet you in person first I will shake hands with you for filing FDA IND application and then I will give you a
tight S L A P from shareholders behalf for ignoring them.
I HATE TO SEE PPS falling to pathetic levels.
It is no surprise MMs will manipulate the PPS to lowest level possible if KOOS goes for hibernation.
Every investor should take a little effort to email Dr. Koos and get following info.
1) What date FDA received IND
2) What date IND number assigned
Based on that we will have some idea about the waiting timeframe for next PR. days/weeks/months...etc...
Why everyone should send email because more the emails there will be high chance he might not NEGLECT it.
David R. Koos email: dkoos@bmsn.us
http://www.cnbc.com/id/100545924
Author says:
I voted yes on Sarepta accelerated approval filing, no on Arena in Europe, a positive Titan panel, FDA approvals for A.P. Pharma, Biogen, Sucampo, Navidea and Raptor. I'm on the fence with Aveo's FDA panel but ultimately predicted a negative vote (just barely, I can see it going the other way, too). I'm definitely negative on Delcath's FDA panel and the ultimate FDA approval decision. Finally, I'm also positive on Ziopharm.
BREAKING Get Wind Of Something_Bio-Matrix Scientific (BMSN) Personnel Now (TODAY) On Pfizer's (PFE) Stem Cell Unit Site in Cambridge, United Kingdom Ventures Sierra World Equity Review. When The Official News Breaks Remember Sierra Told You First!!
Care to share what did you talked to Dr. Koos?
Answer to this question will be greatly appreciated/benefited by MMs and naked shorters i.e. bid whackers.
Good post!
I agree. Well said.
Thanks. I sent one too. I will post the reply here when I get it. Please do the same.
Analyse this:
AMBS: No IND application...Only tested the result on 6 mice...went up to 20 cents and settled well at 7 cents.
BMSN: Trading near a penny. IND will be approved and clinical trial soon on 10 human patients.
No one knows when FDA issued "comments" and when BMSN responded to it. I expect another PR sooner than later. Today's level of PPS will be long history and we will be talking in dimes and nickels very very soon.
If it was Cramer he would have shouted "You need to be in the GAME"
BUY BUY BUY BUY
way way oversold.
Long-ball Hitter_NEW Press Release Coming From Bio-Matrix Scientific (BMSN) Early Next Week To Be a Home Run For Longs_Big Pharma Pfizer (PFE) Active Again In Biotech Buyouts Predicts Sierra World Equity Review
Good catch there Ulatec!
Read the following in the PR:
As part of the clinical trial approval process, the FDA will issue comments on the proposed trial which must be addressed to the FDA's satisfaction before patient dosing is initiated.
This looks like FDA wants to make sure PATIENTS SELECTION for trial meet the required condition for the trial. If patients are selected as per satisfactory mandatory conditions then only FDA will let the trial begin.
The reaction yesterday was as if IND is REJECTED. I don't see any big issues here.
So in the sample case
DATE OF SUBMISSION: November 5, 2010
DATE OF RECEIPT: November 15, 2010
If same things is true for BMSN then
DATE OF SUBMISSION: Feb 5, 2013
DATE OF RECEIPT: Feb 15, 2013
Then Dr. Koos reporting on March 18th is very much on time. I think people here are worrying for no apparent reason. I myself got upset initially when I saw the PR. But now I am beginning to understand the process better. Thanks for sharing this, T_T23!
Well said!
It is a network website to connect all types of professionals together. You can check following link for Dr. Koos
http://www.linkedin.com/pub/david-koos/9/360/993
Wow. I like your optimistic view !
A CLOSER look at the yesterday's PR:
Dr. Koos stated following in the PR:
As part of the clinical trial approval process, the FDA will issue comments on the proposed trial which must be addressed to the FDA's satisfaction before patient dosing is initiated.
It sounds like FDA is trying to comment on patient criteria s than the application itself meaning FDA seems to be inclined towards GO AHEAD signal.
Also Why assign a IND number if they are going to reject? I would like to know from investors how was the case with the companies where IND was rejected? Was there a assigned IND number??
Dr. Koos also sounded optimistic and a step forward when he said
" We have compiled an internationally-renowned team, consisting of corporate and academic partners, which cover the manufacturing, regulatory, and medical aspects of the project."
I think the next positive PR will definitely shoot this PPS above 5 cents. JMHO.......
Like many traders I was also bit disappointed with today's news after painful waiting period. Hope we hear good news in future.
What was annoying part in today's PR was why Dr. Koos waited almost 40 days after IND receipt date just to announce the news "IND number is assigned but FDA still has to APPROVE it"?? He could have announced that simple PR early also right??
Basically we are in "ON HOLD" situation right now and FDA decision can swing in either direction.
Now how many days again "WAITING PERIOD" before we hear from Dr Koos or FDA?? 1 week??? or 1 month or more months???
Obviously stock PPS reacted in a confused manner. Now until we hear APPROVAL news I see this stock either trading sideways or south.
Amen to that!
Read it again. I am not defending anything.
Just a recap...
PR IND on Feb 5th
IND receipt date say took place on Feb 8th (safer side)
30 calendar days will be completed on March 10th
Completion of 4 Business days after that will be today March 14th
If we hear some PR tomorrow or say on Monday next week stock will start exploding north immediately.
If Dr. Koos keeps quiet and does not update shareholders or respond to phone calls or emails in next few days the stock will start going down. That's a fact!
I will be anticipating a PR from company staring tomorrow March 15th.... Good luck to all!!!
Good post.
Dr. koos told you that?
I assign that task to you. Do let us know
Now 777 @13:08...what does this mean now?
911 are the number of shares
News coming soon?
There you go 911 trade at 12:56:39...I just saw it..
This post needs to be sticky.
I very well predicted today's fall since last week itself. MM accumulated today.
Good news is, on Monday we will be closer to 100% that BMSN is approved compared to today or yesterday. We can conclude following:
1) IND mailed on Feb 5th -->confirmed
2) FDA received by regular mail say latest by 7th --> Done deal
3) 30 days will be over on March 9th. Infact BMSN might get approval on that day from FDA. --> Done deal
4) We can expect great news as early as monday morning (Hope Dr. Koos does not delay any further)
Stock skyrockets!!!!!!!!!! Good luck to all longs!!!
What do you mean? 10K states following
"On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia."
I am glad there are at least few investors on this board who knows importance of filing 10Q on time
You repeated twice in your message "The FDA told me about the 30 day approval process from date filed"
That is wrong because on their official website they have mentioned 30 days start from the date of receipt of IND not filing date.
Now I am not sure if "FDA person" who told you this info is uninformed or you dialed a wrong number or you just made this up
I guess truth will come to surface soon.
Sante1,
Unfortunately your calculations are wrong. It is 30 calendar days from IND receipt date and February has only 28 days. So if Feb 8th is the FDA IND receipt date then 30 days will be over only on March 11th
Again as it is written there "30 days from receipt of your IND" and know one knows for sure IND receipt date. So we can not yet say for sure 30 days are over or not.