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good response. I've been in for a few years it's gets tiresome to hear good news and then watch it not respond.
May the force be with pmcb on the 7th. Along with the power of prayer!
The dark side is strong with this one. I think only news that bring in institutions will get it where it should be. Until then the dark side will control it.
i sure would like to take a peek at those nda's. i bet that would explain a lot of things.
this would be a good question to ask kw on the conference call. how did or how will we get funds for the trial?
my 2 cents on the the manipulation. i think one of the nda's is by someone who has a purchase offer already if certain things happen. they are the ones keeping it low which is why kw hasn't really pushed the issue. i don't think it's dilution and i don't think it's someone(s) trying to put them out of business. the mm's allowed the pps to go above .10 when they needed it to get funding from chardan. now they are keeping it in check again. the short volume is not to make money but to keep the price where it is.
imo (this is for fordman)
lmao!!! boo!!!
i don't foresee any problems tomorrow. the 21st cca will make the process more proactive and agressive. some of the comments here are still looking thru the old conservative fda glasses. i think retesting phase 1 is not an options now. ciab has proven to be safe to the body and the drugs are already approved.
imo, tomorrow is just a formality. they have already been enlisting candidates and trials will start in 30 days. we all know that they have had plenty of time to prepare for this.
how about this one trick pony for $5.2 billion.
On Jan 13, we issued an updated report on ARIAD Pharmaceuticals, Inc. ARIA. ARIAD’s one-month share price movement shows that the stock has significantly outperformed the Zacks classified Medical-Drugs industry. Specifically, the company gained 89.2% during this period, while the industry lost 4%.
Notably, ARIAD’s shares got a boost after the company entered into a definitive agreement to be acquired by Takeda Pharmaceutical for approximately $5.2 billion in Jan 2017. The transaction is slated to close in the first quarter of 2017. Through the acquisition, Takeda will add ARIAD’s sole marketed product, Iclusig, to its portfolio.
In Nov 2016, the FDA granted a full approval to Iclusig following its successful completion of the commitments made on the receipt of accelerated approval in Dec 2012. Iclusig is approved in both the U.S. and the EU for the treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). In Sep 2016, Iclusig was approved in Japan and is being marketed by partner Otsuka.
from the fda on pre in meetings
http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf
The following situations are examples of when a meeting can be cancelled:
•
The sponsor or applicant determines that premeeting responses to its questions are sufficient for its needs and additional discussion is not necessary (see section VIII.). In this case, the sponsor or applicant should contact the CDER RPM or appropriate point of contact in CBER to request cancellation of the meeting. The division will consider whether it agrees that the meeting should be cancelled. Some meetings, particularly milestone meetings, can be valuable because of the broad discussion they generate and the opportunity for the division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure, particular safety concerns), even if the premeeting communications seem sufficient to answer the sponsor’s or applicant’s questions. If the division agrees that the meeting can be cancelled, the division will document the reason for cancellation and the premeeting communication will represent the final responses and the official record.
VIII. PREMEETINGS AND COMMUNICATIONS WITH SPONSORS OR APPLICANTS
CBER and CDER hold internal meetings to discuss meeting packages and to gain internal agreement on the preliminary responses to a sponsor’s or applicant’s questions. We may communicate these preliminary responses to the sponsor or applicant. Communications before the meeting between sponsors or applicants and the FDA, including preliminary responses, can serve as a foundation for discussion or can be the final meeting responses. Nevertheless, premeeting communications should not be construed as final unless there is agreement between sponsor or applicant and the FDA that additional discussion is not necessary. Preliminary responses communicated by the FDA are not intended to generate the submission of a new meeting agenda and new questions. If, however, a sponsor or applicant provides new data or a revised or new proposal, the FDA may not be able to provide comments on the new data or it may generate the need for the submission of a new meeting request by the sponsor or applicant.
from the fda on pre in meetings
http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf
The following situations are examples of when a meeting can be cancelled:
•
The sponsor or applicant determines that premeeting responses to its questions are sufficient for its needs and additional discussion is not necessary (see section VIII.). In this case, the sponsor or applicant should contact the CDER RPM or appropriate point of contact in CBER to request cancellation of the meeting. The division will consider whether it agrees that the meeting should be cancelled. Some meetings, particularly milestone meetings, can be valuable because of the broad discussion they generate and the opportunity for the division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure, particular safety concerns), even if the premeeting communications seem sufficient to answer the sponsor’s or applicant’s questions. If the division agrees that the meeting can be cancelled, the division will document the reason for cancellation and the premeeting communication will represent the final responses and the official record.
VIII. PREMEETINGS AND COMMUNICATIONS WITH SPONSORS OR APPLICANTS
CBER and CDER hold internal meetings to discuss meeting packages and to gain internal agreement on the preliminary responses to a sponsor’s or applicant’s questions. We may communicate these preliminary responses to the sponsor or applicant. Communications before the meeting between sponsors or applicants and the FDA, including preliminary responses, can serve as a foundation for discussion or can be the final meeting responses. Nevertheless, premeeting communications should not be construed as final unless there is agreement between sponsor or applicant and the FDA that additional discussion is not necessary. Preliminary responses communicated by the FDA are not intended to generate the submission of a new meeting agenda and new questions. If, however, a sponsor or applicant provides new data or a revised or new proposal, the FDA may not be able to provide comments on the new data or it may generate the need for the submission of a new meeting request by the sponsor or applicant.
from the fda on pre in meetings
http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf
The following situations are examples of when a meeting can be cancelled:
•
The sponsor or applicant determines that premeeting responses to its questions are sufficient for its needs and additional discussion is not necessary (see section VIII.). In this case, the sponsor or applicant should contact the CDER RPM or appropriate point of contact in CBER to request cancellation of the meeting. The division will consider whether it agrees that the meeting should be cancelled. Some meetings, particularly milestone meetings, can be valuable because of the broad discussion they generate and the opportunity for the division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure, particular safety concerns), even if the premeeting communications seem sufficient to answer the sponsor’s or applicant’s questions. If the division agrees that the meeting can be cancelled, the division will document the reason for cancellation and the premeeting communication will represent the final responses and the official record.
VIII. PREMEETINGS AND COMMUNICATIONS WITH SPONSORS OR APPLICANTS
CBER and CDER hold internal meetings to discuss meeting packages and to gain internal agreement on the preliminary responses to a sponsor’s or applicant’s questions. We may communicate these preliminary responses to the sponsor or applicant. Communications before the meeting between sponsors or applicants and the FDA, including preliminary responses, can serve as a foundation for discussion or can be the final meeting responses. Nevertheless, premeeting communications should not be construed as final unless there is agreement between sponsor or applicant and the FDA that additional discussion is not necessary. Preliminary responses communicated by the FDA are not intended to generate the submission of a new meeting agenda and new questions. If, however, a sponsor or applicant provides new data or a revised or new proposal, the FDA may not be able to provide comments on the new data or it may generate the need for the submission of a new meeting request by the sponsor or applicant.
i think that the meeting on tuesday is just the formal final meeting. both parties are in communication after the the pre ind package has been sent and the meeting has been granted. they don't wait until the meeting to answers all issues and questions.
all oncologist know just about every trial that is going on. my aunt has terminal lung cancer that has spread. she said that her doctor told her she didn't qualify for any current trials because of the advanced nature of her cancer. she didn't have a clue about being in a trial or asking to be in a trial. her doctor is the one who brought it up.
correct me if i am wrong but i remember reading somewhere that in the earlier trials, there was total remission from days 2-6. will that be better with the new and improved trials???
from the fda, part of it's q&a section.
Can pre-IND meetings be helpful in developing a strategy for drug development? Yes. The following can be helpful in developing a strategy:
•Identifying studies that will support the initiation of clinical trials
•Discussing available methods to enhance development, for example: ?Orphan Drug Designation
?Fast Track Designation
?Accelerated Approval
?Animal Efficacy Rule
•Discussing the differences between submitting a 505(b)(1) or 505(b)(2) application
good stuff! everything new that is happening in washington just seem to benefit pmcb. also, i may have to buy some btx after reading this article.
just remember "unmet needs" approvals probability are going up big time in 2017 and years to come. the body doesn't reject ciab. think of all of the uses it could and will have going forward. i still think it's comparable to owning the patent to something like the hypodermic needle. it will be the new norm for drug administration, direct problem area treatment rather than the entire blood stream.
small world isn't it. i live down hwy 231 in murfreesboro. i go to mt juliet to get my fix for cajun food. an old Louisiana retiree lives there and he makes homemade gumbo and jambalaya that he sells out of his workshop/store. it's the real deal.
i'm going to tiny west port, indiana tomorrow, about 1 hour se of indianapolis
why worry about dilution? buy now while it is cheap. whats the difference if there is 850 million or 1 billion if it sells for 10's of billions of dollars. oh, i only got $10 per share instead of $12 per share. it is selling for $.15!!! it's what you think the future worth is for pmcb.
don't worry about dilution. you are losing more by waiting to buy at these low prices.
Pre ind packages must be sent 4weeks ahead of meeting (1-12-17). However, if all questions and issues are resolved and agreed upon before the meeting, the meeting will be cancelled. The applicant then waits 30 days for the final minutes from the fda. (2-11-17). Trials can start. Dates listed are estimates.
sorry, i see it now. oh well, i just leave again
whay was this deleted yesterday?
from sen lamar alexander (tn) in the tennessean yesterday. dr collins head of the nih, who is getting the lion share of the 21st cca money mentioned artificial pancreas first!!! the external ones are already on the market so is he talking about melligan/ciab???
Last week Congress and President Obama delivered a Christmas miracle called “21st Century Cures” that will help improve the health of virtually every Tennessean.
This $6.3 billion bipartisan law will help us find cures for cancer, fight opioid addiction, treat mental illness, and better understand the brain to prevent diseases like Alzheimer’s.
It will help take advantage of this remarkable time in biomedical innovation, spur treatments and cures from cancer to rare pediatric diseases, and help move those treatments and cures more efficiently into medicine cabinets and doctors’ offices, while maintaining our gold standard of safety.
The president said this bipartisan legislation was “an opportunity to save lives, and an opportunity we just can’t miss.”
U.S. Senate Majority Leader Mitch McConnell called it “the most important legislation Congress will pass this year.”
I’ve worked on this bill for two years as chair of the Senate health committee. Working with the senior Democrat Patty Murray, D-Wash., we held 12 hearings, led five working groups, and passed 19 pieces of bipartisan legislation that formed much of the policies in this bill.
Working with our counterparts on the House health committee, Chairman Fred Upton, R-Mich., and Democrats Frank Pallone, D-N.J., and Diana DeGette, D-Colo., we also put together a surge of funding to help make dramatic strides in cancer treatments, to help advance our understanding of the brain and Alzheimer’s, and to help achieve the promise of precision medicine, or specific, individualized treatments tailored to each person’s unique genome and environment.
Dr. Francis Collins, the head of the National Institutes of Health, has made “bold predictions” about the breathtaking advances to expect during the next decade from medical research: an artificial pancreas to treat diabetes, vaccines for HIV/AIDS and Zika, a universal flu vaccine, non-addictive pain medicines, a heart built from a patient’s own cells, and early detection or even prevention of Alzheimer’s.
Especially important for Tennessee, the bill will provide $1 billion in grants to states to help fight the opioid crisis.
The new law also will help the one in five adults in this country who suffer from a mental illness get the treatment they need by the making the largest reforms to major mental health programs in a decade.
It also takes a significant step to help more Americans take advantage of regenerative medicine, which the Mayo Clinic has described as a “game-changing area of medicine with the potential to fully heal damaged tissues and organs.”
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Nashville resident Doug Oliver has been an advocate for regenerative medicine. Doug was blind for more than a decade before doctors used stem cells from his hip and injected them into his eye and miraculously restored his sight. He has traveled to Washington multiple times to share his story and even helped my staff craft pieces of this legislation.
Former Senate Majority Leader Bill Frist of Tennessee has worked for two years with the Bipartisan Policy Center to help advance the legislation.
21st Century Cures will modernize the Food and Drug Administration. While biomedical research is making today one of the most exciting times ever in the field of medicine, our federal review and approval process takes too long and costs too much.
The bill improves electronic health records to reduce the documentation burden for doctors and make it easier for patients to access their records and for doctors and hospitals to get the information they need to treat patients.
All these pieces will work together to help improve the lives and health of virtually every Tennessee family. That’s why this new bipartisan law is a Christmas miracle.
U.S. Sen. Lamar Alexander is chairman of the senate’s Health, Education, Labor and Pensions Committee and principal sponsor, along with Sen. Patty Murray, D. Wash., of “21st Century Cures."
OMG!!! This is a letter from Sen Lamar Alexander who spearheaded the 21st CCA with Sen Upton in today's Tennessean (Nashville newspaper) Check out Dr Collins first disease mentioned, ARTIFiCIAL PANCREAS!!!!
NIH gets the lion share of the money!!!
Last week Congress and President Obama delivered a Christmas miracle called “21st Century Cures” that will help improve the health of virtually every Tennessean.
This $6.3 billion bipartisan law will help us find cures for cancer, fight opioid addiction, treat mental illness, and better understand the brain to prevent diseases like Alzheimer’s.
It will help take advantage of this remarkable time in biomedical innovation, spur treatments and cures from cancer to rare pediatric diseases, and help move those treatments and cures more efficiently into medicine cabinets and doctors’ offices, while maintaining our gold standard of safety.
The president said this bipartisan legislation was “an opportunity to save lives, and an opportunity we just can’t miss.”
U.S. Senate Majority Leader Mitch McConnell called it “the most important legislation Congress will pass this year.”
I’ve worked on this bill for two years as chair of the Senate health committee. Working with the senior Democrat Patty Murray, D-Wash., we held 12 hearings, led five working groups, and passed 19 pieces of bipartisan legislation that formed much of the policies in this bill.
Working with our counterparts on the House health committee, Chairman Fred Upton, R-Mich., and Democrats Frank Pallone, D-N.J., and Diana DeGette, D-Colo., we also put together a surge of funding to help make dramatic strides in cancer treatments, to help advance our understanding of the brain and Alzheimer’s, and to help achieve the promise of precision medicine, or specific, individualized treatments tailored to each person’s unique genome and environment.
Dr. Francis Collins, the head of the National Institutes of Health, has made “bold predictions” about the breathtaking advances to expect during the next decade from medical research: an artificial pancreas to treat diabetes, vaccines for HIV/AIDS and Zika, a universal flu vaccine, non-addictive pain medicines, a heart built from a patient’s own cells, and early detection or even prevention of Alzheimer’s.
Especially important for Tennessee, the bill will provide $1 billion in grants to states to help fight the opioid crisis.
The new law also will help the one in five adults in this country who suffer from a mental illness get the treatment they need by the making the largest reforms to major mental health programs in a decade.
It also takes a significant step to help more Americans take advantage of regenerative medicine, which the Mayo Clinic has described as a “game-changing area of medicine with the potential to fully heal damaged tissues and organs.”
Nashville resident Doug Oliver has been an advocate for regenerative medicine. Doug was blind for more than a decade before doctors used stem cells from his hip and injected them into his eye and miraculously restored his sight. He has traveled to Washington multiple times to share his story and even helped my staff craft pieces of this legislation.
Former Senate Majority Leader Bill Frist of Tennessee has worked for two years with the Bipartisan Policy Center to help advance the legislation.
21st Century Cures will modernize the Food and Drug Administration. While biomedical research is making today one of the most exciting times ever in the field of medicine, our federal review and approval process takes too long and costs too much.
The bill improves electronic health records to reduce the documentation burden for doctors and make it easier for patients to access their records and for doctors and hospitals to get the information they need to treat patients.
All these pieces will work together to help improve the lives and health of virtually every Tennessee family. That’s why this new bipartisan law is a Christmas miracle.
U.S. Sen. Lamar Alexander is chairman of the senate’s Health, Education, Labor and Pensions Committee and principal sponsor, along with Sen. Patty Murray, D. Wash., of “21st Century Cures
if we have another run late today with volume and price, i'd say we will get news on the ind meeting on monday. i bet they know already.
c'mon .16!!!
maybe we will have that late day surge like yesterday
lets make pmcb the first to pass thru the fda because of the 21st cca!!! the timing is perfect and the law is perfect for pmcb.
i find this very interesting. 50 million shorted since november 7 and the price has gone up so that tells me they haven't covered yet. that is 5.9 % and about 10 days to cover based on the average volume.
http://www.pbs.org/newshour/rundown/wins-loses-21st-century-cures-act/
WASHINGTON — Sponsors of the 21st Century Cures Act call it a win-win: a fusion of funds for medical research with new rules that direct the Food and Drug Administration to approve drugs and devices with greater urgency. There’s also money to help states fight the opioid epidemic, and a boost for mental health care.
But this is Washington, so even this bipartisan bill, which the House of Representatives approved in a landslide and which the Senate is expected to pass Tuesday, leaves a trail of winners and losers.
Winner: Drug companies
More than 1,300 lobbyists roamed the halls of Congress on the Cures Act, and disclosure reports show most of them were working for pharmaceutical companies.
Their work has paid off.
Among other measures, the legislation calls for the use of “data summaries” to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.
They did not get everything they asked for, however. Among the provisions that the Democrats beat back was longer market exclusivity for certain drugs.
READ MORE: House approves the 21st Century Cures Act, sending landmark bill to Senate
Winner: Medical device manufacturers
According to the Advanced Medical Technology Association, which represents 300 medical device companies, the Cures Act builds on FDA’s current programs to allow a quicker path for breakthrough medical technologies for patients with life-threatening or irreversibly debilitating diseases or conditions, and limited alternatives.
“Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new lifesaving, life-enhancing devices and diagnostics for patients,” said the group’s president, Scott Whitaker.
Critics of the measure, such as Public Citizen’s Health Research Group, say the designation of “breakthrough” devices is too broad, and could lead to clearance of devices that aren’t ready for the market.
Winner: National Institutes of Health
An earlier House version of the legislation called for the NIH to get an $8.75 billion boost in its budget. The current legislation includes just more than half that amount for the agency: $4.8 billion. But, with an incoming president who has called the nation’s medical research agency “terrible,” it could have been worse.
The landmark legislation provides funding for three signature Obama administration research programs, over the next 10 years: the “moonshot” against cancer, the BRAIN Initiative, and the Precision Medicine Initiative.
READ MORE: 21st Century Cures Act will distort the meaning of ‘FDA approved’
Loser: FDA
The $500 million designated for the FDA is meant to pay for the agency’s new responsibilities under the Cures Act. There is virtually nothing in it to improve some of FDA’s longtime problems.
The Government Accountability Office considers two of the FDA’s areas of focus especially “high-risk”: food safety and post-approval oversight of medical products that went through the fast track.
There’s also no money in the Cures Act for aging, deteriorating labs, outside of headquarters, which Commissioner Dr. Robert Califf has said pose a serious problem.
Winner: ‘Real world evidence’
The Cures Act directs the FDA to evaluate the use of “real world evidence” for approval of new indications for FDA-approved drugs. Proponents see this as a way to apply useful and timely information learned from observational studies, patient input, anecdotal data, and other research to drug and device approval.
Loser: Randomized clinical trials
Currently the gold standard for testing drugs and devices for safety, the adoption of real world evidence standards may indicate that randomized clinical trials will become less important for drug and device approval.
Winners: Representatives Fred Upton (R-Mich.), Diana DeGette (D-Colo.) and Tim Murphy (R-Pa.)
For Upton, who must step down in January as chairman of the House Energy and Commerce Committee, passage of the Cures Act has been a near obsession. For more than three years, Upton, along with DeGette, has herded patient advocacy groups, the drug and device industry, and even rock star Roger Daltrey to support his cause. The payoff: a 392-to-26 vote.
Upton also got a bonus: More than $1.3 million in donations from health care political action committees during the time he was crafting the bill.
Murphy, a psychologist, is an unexpected victor. Merely days before the vote, the House leadership attached his mental health legislation to the Cures package.
Dr. Maria A. Oquendo, president of the American Psychiatric Association, praised the mental health provisions in the Cures Act, and said it will greatly benefit patients. The legislation includes money to create suicide-prevention programs and to improve mental health services for children. It also allocated the $1 billion in state grants for the opioid epidemic, and seeks to strengthen laws that require the government and insurers to treat mental illness like other diseases.
“Congress has finally come together in a bipartisan effort to bring serious mental illness out of the shadows,” Murphy said. “It is my pledge to the patients and families in crisis that I will never stop fighting to deliver treatment before tragedy for those most in need.”
READ MORE: The Who’s Roger Daltrey: Teens with cancer deserve better
Winner: Senator Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions
Since July 2015, when the House passed a draft of the Cures Act and sent it to Alexander’s committee, the Tennessee lawmaker has had to overcome enormous opposition from both Democrats and Republicans.
His GOP colleagues vowed to reject any legislation that cost money — no matter how noble its goal — unless the cash was cut from another program.
The Democrats did not view the Cures Act’s main purpose — “acceleration” of FDA’s work — as especially noble. Most of them believe the agency already works fast enough, perhaps too fast, and needs to maintain its status as the global regulatory leader in patient protection.
So Alexander devised a plan: He chopped the Cures Act into small “medical innovation” bills, which had committee consensus. These ranged from measures to help NIH hire and retain scientists to developing better ways of managing electronic health records. Then, he took the hard stuff to the Senate and House leadership, who crafted the current compromise.
Loser: Senator Elizabeth Warren (D-Mass.)
Warren took to the Senate floor last week to rail against the Cures Act, saying it had been “hijacked” by the pharmaceutical industry. She said the legislation watered down safety requirements for new drugs and devices and then, as a trade-off, called for research funding — at levels that must be appropriated on an annual basis
“I cannot vote for this bill,’’ Warren said to a largely empty chamber. “I will fight it because I know the difference between compromise and extortion.”
Warren returned the next day with reinforcements: Sen. Dick Durbin of Illinois, and Sen. Jeff Merkley of Oregon, who agreed that the Cures Bill should be stopped. But she could not get majority support, even in her own party.
READ MORE: Elizabeth Warren rips 21st Century Cures bill and vows to fight it
Winner: Vice President Joe Biden
Since the death of his son, Beau Biden, from brain cancer, the vice president has devoted himself to a cancer “moonshot,” designed to speed cures by compressing 10 years of medical research into five.
The initiative faced an uncertain future under the new administration, but the Cures Act saves it, by authorizing $1.8 billion over five years to continue the program.
Congressional leaders praised Biden for his work on the bill, which the White House supports.
Winner: Michael Milken’s FasterCures and a host of patient advocacy groups
Michael Milken, the former junk-bond king turned philanthropist, has hosted retreats and receptions from Lake Tahoe, Nev., to New York, putting lawmakers in front of renowned scientists, patient advocates, Cabinet secretaries, and biomedical industry chief executives — all with the objective of winning support for medical innovation.
His Milken Institute center, FasterCures, was integral to developing support for the Cures bill. Other groups, including the American Cancer Society Action Network and Research!America, all supported the Cures Act — although some expressed disappointment with the reduced funding.
Losers: Consumer advocacy groups
Public Citizen’s Health Research Group and the National Center for Health Research campaigned hard against the Cures Act. Although they were able to make some changes, both organizations believe the Cures Act, as it stands, will endanger public health by weakening FDA standards.
Loser: Regenerative medicine
Senator Mark Kirk of Illinois, who had a stroke in 2012, introduced the REGROW Act earlier this year, to expand treatments for stroke victims and people suffering from Alzheimer’s, Parkinson’s and diabetes. Kirk’s legislation, which GOP leaders tried to include in the Cures Act, would have permitted the FDA to approve stem cell treatments conditionally, without a large, final-stage clinical trial that is usually required.
But many researchers argued that stem cell therapies are still in the early stages of safety and efficacy, and urged Congress to hold off giving FDA such a mandate.
The final Cures draft does not allow new regenerative medicine products, which include stem cell therapies, to skip the Phase 3 trials. But it does permit FDA to grant them accelerated approval if they can show that surrogate endpoints might indicate the drug works, subject to further study.
i use my roth as my fun money acct. all of my shares are in that.
if we are processing enrollment for the trials, i'd say we have funding already, at least for the pc trials.
https://www.journaltranscript.com/2016/12/pharmacyte-biotech-inc-otcmktspmcb-progress-with-patients-enrollment-in-pancreatic-cancer-clinical-study/
it puts emphasis on "unmet needs". ciab has "unmet needs" written all over it.
yes
The teleconference is a popular meeting format because they are easier to schedule and manage and are less costly than face-to-face meetings. Speculative and open-ended questions are difficult to address; meetings are typically most productive when questions are focused and specific. Questions for the FDA should be posed in such a way that the agency can either agree or disagree with the question
http://www.oraclinical.com/articles/basics-pre-ind-meeting
a big news release would be sweet about right now
you mean
knock, knock, knocking on 7's door.
sorry, this is the first thing that came to my mind