and CBS news
and just hit the airwaves via Rueters in INDIA and AUSTRALIA
Reading posts, enjoying and thanking Al Mann for his persistence... thank you Dr Mann,
Not the least bit worried, we will see this stock reach 20s shortly. Not worried about partners, they will come without MNKD having to court them. Wondering what else Technosphere can be used for..
Thanking the all true believers in the stock, the company and technology. Thank you, you know who you are.
Message to diabetics: I hope this product eases your pain and suffering. No cure, but hopefully it helps you manage your condition more efficiently and effectively.
Peace all.. I sleep well tonight!
The really got taken out. I wish I was by a computer when I found out; would have bought MORE!
By the way-- Here's an excerpt from FDA release:
"The FDA is requiring the following post-marketing studies for Afrezza:
a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;"
MNKD to the MOON !
A day after Sanofi (SAN) announced a diabetes alliance with Medtronic Inc. (MDT), its research chief said the Paris-based drugmaker may seek other partnerships to expand in one of the fastest-growing medical conditions.
“We are open-minded” on other possible partnerships or acquisitions in diabetes, said Elias Zerhouni, Sanofi’s head of research and development, in a telephone interview. “We want to absolutely excel in the injectable space and I think that’s what we are accomplishing, but that is still going to be half of the market. We will be opportunistic.”
Sanofi, which makes the top-selling insulin Lantus, and Medtronic, the biggest maker of heart-rhythm devices, yesterday said they’ll work together to develop combinations of diabetes medicines and devices, and seek technology-based services to simplify insulin use and improve treatment compliance.
ditto here. I do know that the FDA would have hell to pay if they don't approve the drug; and the only reason I see why they may not approve it would be political and the FDA reviewers being paid off by a competitor of MNKD.
Correct and they had rejected it after the first adcom unanimously voted in favor of approval in 2008 when the drug was owned by Schering-Plough
Want to stay real here.The FDA did reject Merck's sugammadex at least twice after an advisory committee unanimously approved the drug.
Doesn't mean MNKD will get rejected, but there is always a small chance
Agreed. I may not be investor in MNKD for a long time, but I have been buying. i also intend to stick it out a lot longer than 6-8 weeks. Simply because I believe that MNKD is about to revolutionize the inhalable drug market!!
no so the positions state experience with GMP regulations as a requirement. GMP regulations continue even after approval as an ongoing check; so I see them preparing for approval. Also it could be that the FDA advised them that they must have GMP compliance people on staff as a condition for approval (inspectors and regulators working with the company-- isn't that what they stated in the last meeting? - ) so hence they are moving forward and it could be that the FDA already inspected. That's my take
So some of the jobs require an understanding of GMP regulations.
Here's what the FDA describes what are GMP regulations:
"Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations
FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.
FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug."
REPEAT: "The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP."
Looks to me like the manufacturing facility was just inspected and the FDA wants to ensure MNKD follows GMP. Approval is a given!
Can I ask if anyone know if these weekend positions are in addition to the weekday positions? and are the weekday positions also day and night shifts? If so then we have a 24/7/365 operation
For all of us who hope to make a LOT of $$s on the approval of Afrezza, I offer a perspective I found at the ADA sight. I for one hope we do make a lot of $$s but more importantly I hope this offers a REAL solution and alternatives to diabetics--
The great thing about Afrezza is NOT the delivery system (despite what the company seems to think). They are "burying the lead" as they say in the news business. We Type-1ers are used to syringes and that's the least of our worries. The real advantage, and it's a huge one everyone here seams to be ignoring, is the speed with which Afrezza kicks in. It's ULTRA rapid. Closest to a real pancreas's timing. If they want to succeed at marketing this product, they need to stress that over the inhaler aspect. Those of us who use pumps already bypass needles for the most part but it still takes 15-30 minutes for our insulin to work.