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.
Outside money accumulating. Ihub money playing.
Lol yup but they'll get stuck one day. Considering usrm has issued subpoenas to ihub before, it wouldn't surprise me that they see this and drop a news bomb on the shorts lol it's public record dade county courts clerk of court
Agreed but I think with the new administration (trump, gottlieb, and friends) big pharma will just be forced to buy these stem cell companies out. I mean the FDA has created a new department within, specifically geared towards stem cells, gene therapy, etc. I believe the tides are already heading in that direction.
That's when she dropped the mic on the FDA lol
Benefits of RAT Designation
RAT designation affords the following benefits to sponsors:
Expedited development and review by FDA (i.e., the same actions as for breakthrough therapy designation);
Early interactions “to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of the product;” and
Eligibility for accelerated approval under current FDA preapproval standards but with new postapproval requirements.
Signaling for Expanded Use of Accelerated Approval
The new postapproval requirements are a key differentiating factor from the breakthrough therapy designation. Sponsors of RAT-designated products approved via the accelerated approval pathway have additional options to meet post-approval requirements beyond the standard, controlled clinical trial. Post-approval requirements[color=red][/color] can be met through:
Clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records;
The collection of larger confirmatory data sets; or
[color=red]Postapproval monitoring of all patients treated with such therapy prior to approval of the therapy.
The new designation, therefore, encourages FDA to further develop and utilize the Subpart H/accelerated approval pathway. For a comprehensive review of FDA’s use of accelerated approval, refer to our paper, here.
Notably, the January 2015 House version of 21st Century Cures at section 2041 addressed regenerative medicine from a different angle. It directed FDA to issue a guidance document on surrogate and intermediate endpoints for accelerated approval of regenerative medicine products. Although this original approach was less ambitious, it also highlighted the need for accelerated approval to bring to market products in the budding field of regenerative medicine.
Saw this yesterday and copied it from mtlebomac
"New" MM: LAFC
Wants to play at .175
LAFC = marketmaker R. F. Lafferty & Co., Inc.
Their Investment Banking services include:
* Mergers and Acquisitions
* Reverse Mergers
* PIPE Transactions
* Private Placements
* Initial Public Offerings
* Bridge Financing
* Assistance with Exchange Listings
Wrong. Phase 2 has been completed. RMAT allows you to essentially go into commercialization, providing data as you go. Essentially skipping phase 3
Benefits of RAT Designation
RAT designation affords the following benefits to sponsors:
Expedited development and review by FDA (i.e., the same actions as for breakthrough therapy designation);
Early interactions “to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of the product;” and
Eligibility for accelerated approval under current FDA preapproval standards but with new postapproval requirements.
Signaling for Expanded Use of Accelerated Approval
The new postapproval requirements are a key differentiating factor from the breakthrough therapy designation. Sponsors of RAT-designated products approved via the accelerated approval pathway have additional options to meet post-approval requirements beyond the standard, controlled clinical trial. Post-approval requirements can be met through:
Clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records;
The collection of larger confirmatory data sets; or
Postapproval monitoring of all patients treated with such therapy prior to approval of the therapy.
The new designation, therefore, encourages FDA to further develop and utilize the Subpart H/accelerated approval pathway. For a comprehensive review of FDA’s use of accelerated approval, refer to our paper, here.
Notably, the January 2015 House version of 21st Century Cures at section 2041 addressed regenerative medicine from a different angle. It directed FDA to issue a guidance document on surrogate and intermediate endpoints for accelerated approval of regenerative medicine products. Although this original approach was less ambitious, it also highlighted the need for accelerated approval to bring to market products in the budding field of regenerative medicine.
Or a takeover attempt lol either way we're all winners here !!
http://www.investopedia.com/terms/h/hostiletakeover.asp
Could the recent smear campaign have been a poison pill?
Is this really that far-fetched? I don't think so considering all that's been going on here
Lol bids going way above ask.
The dip here hasn't changed any of the DD up in the stickies. This thing is getting ready
Expecting some big news this week.
The real fun here begins after lunch haha just wait. Clockwork
Like clockwork!
The DD here is undeniably amazing!
Exactly! I think UK investors are here. Big ones
Lol reread my posts. I wasn't downplaying anything. Do some DD. Europe is huge for usrm lol
Europe is mentioned many times in the 10k. Hippos DD posts contain many European connections. Our scientific advisory board has many doctors in EUrope.
Imo this company is just waiting for the right time to drop some bombs on us. Money bombs
News from the U.K. Hmmm think about it.
Still too early to look at L2
A lot of our clinical data for these trials are coming from overseas. Mexico, Europe, Asia... its all in the stickies and links above. Imo a lot of the big money coming in now is also from overseas as the pivotal trials are FINALLY coming to an end. Now think about it. What happens when the FDA gives a thumbs up for RMAT designation? BIG US money comes in. This is an international powerhouse just getting started. Hold on tight
The last few trading days we've seen some flurries of HUGE buys. Hmmmm
And there it is folks. The coveted .10
I expect a few more form 4's before news is released
That'll be here sooner than we think imo haha
Mm's getting frustrated haha
It also allows you to analyze the market makers and their games
Was in the 300s a couple weeks ago!
This is actually churning nicely. What happened the last time it did this??
Mm's flashing huge fake sells lol
She's strong
Damn I really wanted some 4's!! Lmao
Market maker aka money mover, market manipulator, the middle man
This guy just trolls the top boards claiming pump n dump. Look at his post history lol disregard
Hungryhippo, that new sticky is looking real good up there. Cheers. Glta
Exactly. Trump likes looking good. This helps him look good. Imo it's a no brainer here. The FDA would be foolish, with the current political climate, to turn this down.
Trump and the new FDA director are outspokenly pro stem cell. Trump wants to find a way to implement cheaper healthcare, deregulating the FDA and opening the doors to less invasive, less expensive healthcare alternatives. Trump usually gets what he wants, like it or not. Imo us stem cell is in the right place at the right time with the right people to get it done. The new FDA director will want to impress trump, thus FDA RMAT designation and fast track for usrm. Not that far fetched. It's coming.
But will they defy trump and the new FDA director who is very outspokenly pro stem cell? Imo he (gotlieb) will help push these new treatments through, forcing big pharma to get in the game (buyout)