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IND approval is like hitting a Royal Flush.....
The rch• pr today indicates they completed GMP certified lab work required by the FDA, they are now seeking FDA approval......sounds like they are only a step ahead of us.....shows how hungry the market is for successful microcap biotechs, and how quickly circumstances can change here.
Jim Marrs' presentation on Ancient Alien Technology (youtube) provides an introduction to the forces fighting against the fallen angels. Richard Dolan's breakaway civilization thesis (youtube) is another. Although, most information still remains classified. Happy superbowl weekend! BMSN/RGBP/ENTB
Your inquiry is answered in CFR 21 Part 316.
§316.24 Deficiency letters and granting orphan-drug designation.
(a) FDA will send a deficiency letter to the sponsor if the request for orphan-drug designation lacks information required under §§316.20 and 316.21, or contains inaccurate or incomplete information. FDA may consider a designation request voluntarily withdrawn if the sponsor fails to respond to the deficiency letter within 1 year of issuance of the deficiency letter, unless within that same timeframe the sponsor requests in writing an extension of time to respond. This request must include the reason(s) for the requested extension and the length of time of the requested extension. FDA will grant all reasonable requests for an extension. In the event FDA denies a request for an extension of time, FDA may consider the designation request voluntarily withdrawn. In the event FDA considers a designation request voluntarily withdrawn, FDA will so notify the sponsor in writing.
Also of interest, Dr. Koos can submit orphan application at any phase of the development before a marketing application.
§316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
Even if the application is denied, Dr. Koos has the opportunity to file an amendment.
§316.26 Amendment to orphan-drug designation.
(b) FDA will grant the amendment if it finds that the initial designation request was made in good faith and that the amendment is intended to conform the orphan-drug designation to the results of unanticipated research findings, to unforeseen developments in the treatment or diagnosis of the disease or condition, or to changes based on FDA recommendations, and that, as of the date of the submission of the amendment request, the amendment would not result in exceeding the prevalence or cost recovery thresholds in §316.21(a)(1) or (a)(2) upon which the drug was originally designated.
http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=238362420de6b80c19b2a9c44b73a843&rgn=div6&view=text&node=21:5.0.1.1.6.3&idno=21#se21.5.316_123
Final 2 slides from the OOPD presentation states approval takes <90 days 60-70% of applications are approved and if you click the link provided on the final slide it takes you to the OOPD FDA site where you can search orphan drug applications, result: none found for hemaxellerate (denied or approved) Now, Dr. Koos updated the Regen website investor relations in Dec/JAN and still mentions they are seeking orphan status, the recent 8k leads me to believe they are finalizing data or awaiting IND safety approval before submitting an Orphan application....the Nephilim agenda on this board and the affliction of cancer on humanity will be conquered with love and light, ----my authority descends from the book of Enoch, i walk the path of the righteous your time here is coming to an end.
http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM294786.pdf
Orphan Drug Application presentation from the OOPD....incentives: grants and venture capital...hemaxellerate is a perfect match with the data to support....we have two full time Doctors finalizing the data and working the app when ready...pace should start to pick up around here, investors now are ahead of the market and foresee whats ahead.
Penny season is here, markets being primed for immunotherapy, volume increasing, we should have never dropped below .003 for this long, this is golden ticket range...ET's glowing finger is pointing to the star charts, send him home Dr. Koos, he's ready!
Drinks on me then in Miami when we breakthrough this blackhole and go interstsllar!
False, FCC does not permit Cramer to mention penny stocks on tv because the otc is a small limited market, we have a couple bozos on here manipulating, imagine what Cramer could do if he started slamming his buy buy buy button...many of us here would be in miami next week if he did, its not allowed he only mentions big board stocks...immunotherapy is the medical revolution for biotechs, he is calling hot sector for 2015 his exposure will have many researching immunotherapy this weekend and BMSN/RGBP efforts will be found, FDA approval and/or grant/jv will be a market outperform catalyst which Cramer is spotlighting the sector that big pharma is on the hunt, we only need a handful of big board whales to see us down here to ignite ignite ignite...strap in space ranger!
Once RGBP science is proven safe and effective, which we already have a lead on, we will be a frontrunner in this industry that is about to explode, as u can tell from the ASH exhibition excitement and National coverage...almost inevitable that deep pockets like Dr. Soon-Shiong will be involved with the frontrunners
Potential JV or competitior?
Would recommend Koos take a trip to LA next.
Interesting 60 minutes clip on moving cancer treatments out of the dark ages and into the enlightenment...
Watching the immunotherapeutic T-cell eat a cancer cell really nails down why I am invested here...
Links:
http://www.cbs.com/shows/60_minutes/video/UxuTMvSzEe36Th5ykQuuLnFjhmNitutP/disrupting-cancer/
http://www.forbes.com/sites/matthewherper/2014/12/07/here-is-what-60-minutes-didnt-tell-you-about-the-billionaire-who-is-trying-to-disrupt-cancer-care/
Found it: independenceenergycorp.com
From the JUL pr, their sales team has international reach, so i would imagine seeing contracts here soon for both domestic and abroad as other countries start implementing screening procedures at airports
Request website address, post in ibox?
FDA approval for an IND is unheard of in the penny markets, we are about to have two, simultaneously! With the obvious possibility for a JV funding/co-development deal thrown into the mix. Orphan status could propel licensing deals within 60 days, with the multitudes of disorders these cellular therapeutics attack, Koos will have offers lining up and positive cash flow to justify big board listing, investors are about to take an unprecedented journey!
11JUN PR -- Significance -- weekend research
Ok, so I caught part of the NBCNews special with Meredith Vierira "A Leap of Faith" discussion on tracheal stem cell organ transplants, w/ Dr. Paolo Macchiarini, tonight. Recommended viewing, not sure if it will be re-aired yet. Basically, details the start of stem cell organ transplant in humans, the technology is here and now.
http://www.nbcnews.com/feature/a-leap-of-faith/leap-faith-desperate-patients-look-lab-grown-organs-n142036
After viewing, I re-read the 11JUN PR and have a better understanding for what Dr. Min is attempting to accomplish with Dcellvax. Targeted immune suppression. Right now, the difficulty with stem cell organ transplants; patients' bodies do not always accept the transplant and require immune suppressant drugs that impact the entire immune system leading to complications. Dcellvax, through preliminary experimentation, is exhibiting to work cooperatively with stem cell organ transplants. Dcellvax is an application that will allow stem cell organ transplants to be accepted by the patients body! Once proven effective and safe, it is intended to be a "global" application for all stem cell organ transplants.
From Dr. Hawkins TV special a couple months ago and Dr. Macchiarini's work, the momentum and technology is there to grow organs from a patient's stem cells...and it looks like the transplant applications are about to catch up in a very large way. All these hospitals/surgeons/regenerative med. Pharma Companies/etc...involved in stem cell organ transplants for patients with exceptional need medical conditions, will need dcellvax application for surgery recovery and to increase their transplant acceptance, according to the research paper.
TO solidify Min's research, in my mind, a couple more months to file an IND is more than welcomed. We are no longer talking about an application to immune stimulate against breast cancer, this is an application that will be sought out by the entire regenerative medicine community. Landmark/game changing potential.
Why anyone would not be accumulating at these levels for the time we have left, is beyond me, heck, I would be knocking on Koos' door to privately purchase Regen shares if you missed the divy.
Like minds think alike! Happy to be long here, and soon a true blessing this will be, as many investors will soon discover the breakthrough medicine!
Regen10q filed, bmsn10q to follow then entb10q, would be an order of priority for Koos, and on schedule will show he is diligently focused, maybe saving updates on products in the pipeline for bmsn10q since Regen is not trading yet and really no mention of products in the 10q or the recent divy, makes sense to me that the Regen10q would be file requested by Finra before assigning a ticker, opportunity for a pr is upon us ladies and gents and sirs....
Buydontborrow, eagerly want to purchase a shirt here, will they be for sale from tranzbyte website?
Nice! Looking forward to seeing them, i'm a buyer!
At the rate of publicity we have now, erbb could make a killing on marketing souvenir products! Everyone will want a "i got Zazzed in Co" shirt or bumper...
Drudge report! Oh yeah, this is moving tomorrow!
Hrdn about to post a 420 k !
Clark, the Griswolds need a trip to Wallyworld, buy em some hrdn before she rips!
Nice volume!!! Gonna pop to 02's soon at this rate before news, extremely low entry/accumulation price here...CEO timing for trifecta of news once Regen is ready to start trading or before...$$$
Will do, thanks d5, fidelity is on my radar now.
Like Fidelity's style, they may have a new customer here soon. Thanks for the refferal.
He is about to have the entire OTC market with his efforts in the spotlight, great position to be in, hope he has a tight shot-group.
Smartcard should receive a strong response from customers, glad to be in at the ground floor, customer loyalty is a big part of this industry, i have seen loyalty cards where credits for discounts are kept on a smartcard but nothing like this, regulars will now have a chance to keep an account with their favorite store/clinic and avoid going to the atm before making a purchase...efficient, retailers will be signing up left and right to keep their loyalty base...this will explode nationwide once beta testing is complete...excellent direction for FFFC. I'm looking to see if we catch up with ERRB....
Wow nice buy volume today
Any possibilites that the 1:147.7 divy pro rata distro is at a greater rate due to all 2.9b bmsn o/s not in sh hands for whatever reasons?
Thanks sizzle, agree float is locked!
Lower volume sells today, interesting what happened at 1530, 700k block sell, immediately gobbled up, then a series sell of about 700k and immediately gobbled up...both times projecting the price higher...there are sharks here feeding, mm's are about to lose control and shorts are about to be thrown into a feeding frenzy, pretty soon the great whites will be here...longs are looking through their 40ft glass. bottom boat at the action considering upgrading to the cousteau sea explorer, fishing for more...trend will continue till the paradigm shifts!!!!
Explosion will start around .02, we are only now lighting the fires and kicking the tires
Party of the century, i'm there ??
Medical paradigm shifts when FDA grants approval, and we are about to witness this shift firsthand, with fistfuls of shares in our hands, glta
These are aggressively forward thinking companies
Will look for it, i read it yesterday on their board
Recommend any longs conduct dd on benitec, bmsn's partner, there is an excellent seeking alpha article on benitec, not invested there but do believe Regen will be trading at the same level very soon
Once divy window closes, loading up lil sis entb will unlock even more shareholder value, she follows closely at half the price