|
|
Post by mindovermatter on Dec 12, 2015 19:57:06 GMT -5
Suebee, in addition to A1c and blood glucose, did your husband have any other blood work done just prior to starting on Afrzza and if so, has he had any recently and were there any improvements in the other lab results other than glucose and A1c and if my question is too personal, feel free to not answer and I apologize in advance for being so intrusive. My husband had been on Metformin, Glucophage, Onglyza etc for the last 7 years. When his doc told him that an A1c of 7.6 was ok and he wished all of his patients had blood tests so good, we changed doctors and then had to beg, beg, beg for an Afrezza script. A1c dropped over 1% the first 3 months. This stuff is pretty amazing. Waiting for his next three months! Have you thought about writing your old Endo and update him about how well your Husband is doing now that he's on Afrezza, the drug he wouldn't even consider? Might give him something to think about. I know if my wife went through what you and your husband went through, I'd hand deliver if not talk to the doctor face to face and show him the proof. Might not make him change his mind but it would definitely make him think. |
|
|
|
Post by mindovermatter on Dec 11, 2015 15:27:49 GMT -5
My meaning of "answer" was to mean putting out at least one new TS candidate with a new deal. Mannkind investors have been left at the altar by Management, imo. But what do you expect them to say? Its quite obvious things are not going according to plan. The CEO was fired (which needed to happen) and there are multiple road blocks keeping scripts down. A 90 year old is the captain of this ship that is taking on water. We all know this. There is not much positive outside of user reviews. Ive spoken with Matt in email once since I am an investor in MNKD. Go try emailing the CFO of SNY and see when they respond. We are all big boys and girls and they are not here to hold our hand. You are investing in a biotech company and you should automatically assume your money is gone. It sucks right now. Theres no denying that. I buy speculative stocks and MNKD is at the top of the list. You cannot expect to make a 1000% return on your investment without being tortured by the volatility of the share price on its road to success or failure. It is obvious you didn't understand what I wrote as your response has nothing to do with what I wrote. But I enjoyed reading your hissy fit! |
|
|
|
Post by mindovermatter on Dec 11, 2015 13:39:39 GMT -5
What is worse is that Mannkind has proven to have no answer to show they have anything to counter the nay sayers. There isn't a visible pipeline to speak of. I know there is talk about TS candidates but nothing concrete. What you are seeing is directly the result of poor planning by Mannkind. Just thinking out loud but if Al plans on buying shares why would they say anything to bring the price up? My meaning of "answer" was to mean putting out at least one new TS candidate with a new deal. Mannkind investors have been left at the altar by Management, imo. |
|
|
|
Post by mindovermatter on Dec 11, 2015 13:00:40 GMT -5
Tomorrow is here and we are back down 8%. Of corse the overall market is down 280 points. It is criminal how Wall Street is playing with this stock! What is worse is that Mannkind has proven to have no answer to show they have anything to counter the nay sayers. There isn't a visible pipeline to speak of. I know there is talk about TS candidates but nothing concrete. What you are seeing is directly the result of poor planning by Mannkind. |
|
|
|
Post by mindovermatter on Dec 10, 2015 14:09:35 GMT -5
Rhetorical question, since nobody can really answer it, but WOW - look at that share price go!
It seems to me that this might be some short covering. We'll have to pay attention to the volume, I think. After all, it is only 20 cents.  Great if you are day trading it and got in lower otherwise it's the typical 1 step forward 5 steps back. Another question is what happened to announcing the next TS candidate? Didn't management say they'd be announcing it by EOY? OR is that why Hakan stepped down because he was unable to get anyone to commit? |
|
|
|
Post by mindovermatter on Dec 10, 2015 11:06:50 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin"  !!! This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. Or they are assessing if they should further their commitment. Remember, Sanofi is a business. They know how much they want to commit to Afrezza before they pull the plug. Sanofi knows exactly what Afrezza does and how well it works but their problem is convincing doctors and insurance companies. The question is how committed is Sanofi? MNKDs run to the TASE to raise capital tells me that Sanofi wasn't ready to further their commitment to their partner. I could be misinterpreting Mannkind's TASE move but that is how I read the move. If so, the beginning of 2016 is going to be very telling as to the future of Mannkind. |
|
|
|
Post by mindovermatter on Dec 10, 2015 9:43:02 GMT -5
If anyone takes the time to read through the slides you'll see it confirms the issues surrounding the resistance to accepting not just insulin but inhaled insulin in the medical community here in the United States. And I clearly understand why Sanofi has taken the approach it has. The calls for wide spread advertising etc would have been a disaster. This is a marathon not a sprint and Sanofi is preceding with care and caution as it always said it would be. |
|
|
|
Post by mindovermatter on Dec 9, 2015 10:44:22 GMT -5
Would love to hear of a similar meeting with T2's exclusively...but perhaps the powers that be are compiling data from T1's for T2's to eventually follow for optimal results? More thoughts on why T2's were excluded? docfrezza? liane? My thoughts are that SNY knows that T1s are a better fit for Afrezza as T1s are typically more diligent about their disease. Insurance companies, once they realize how well Afrezza works in controlling T1s compared to other meds, will be more interested in covering Afrezza for T1s than T2s who typically have less expensive means to control their diabetes. T2s will take a much longer time to adopt due to pricing. Maybe once insurance and docs see how well Afrezza works for T1s will they then start recommending it to T2s. Remember, Mannkind originally was only going after T1s not T2s. If I recall, the FDA wanted Mannkind to include T2s in their final study. |
|
|
|
Post by mindovermatter on Dec 9, 2015 9:09:19 GMT -5
Did this board go from stock discussion to a therapy support group for longs who are obsessed with FUD? Too bad Mannkind doesn't sell inhalable spines. Some on here are need of one.
|
|
|
|
Post by mindovermatter on Dec 6, 2015 18:28:26 GMT -5
|
|
|
|
Post by mindovermatter on Dec 6, 2015 8:06:23 GMT -5
Has Adam Feuerstein yet made any comments about KBIO and it's absurb valuation based on its lackluster pipeline? I haven't yet seen a word from him on Martin, KBIO or anything regarding the situation. Maybe I just missed it but if my observation is correct, I find it interesting that Adam, the guy who loves to point out problems with biotechs, has remained strangely quiet about his buddy Martin. But maybe that is by design. |
|
|
|
Post by mindovermatter on Dec 4, 2015 18:21:08 GMT -5
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475553.htm[Posted 12/04/2015] AUDIENCE: Pharmacy, Emergency Medicine ISSUE: An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization. FDA issued a Drug Safety Communication in May 2015 warning about the risk of ketoacidosis with SGLT2 inhibitors and alerting that the Agency would continue to evaluate this safety issue. A review of the FDA Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors (see the Drug Safety Communication Data Summary). Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing. FDA also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure. As a result, FDA added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations. FDA is also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years. BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin. RECOMMENDATION: Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis. Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms. Ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high. If ketoacidosis is suspected, the SGLT2 inhibitor should be discontinued and treatment instituted promptly. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/reportDownload form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 [12/04/2015 - Drug Safety Communication - FDA] Previous MedWatch Alert: [05/15/2015] Safety Alerts for Human Medical Products 2015 Safety Alerts for Human Medical Products 2014 Safety Alerts for Human Medical Products 2013 Safety Alerts for Human Medical Products 2012 Safety Alerts for Human Medical Products Page Last Updated: 12/04/2015
|
|
|
|
Post by mindovermatter on Dec 4, 2015 14:39:05 GMT -5
Ok, this site just jumped the shark.
|
|
|
|
Post by mindovermatter on Dec 2, 2015 10:04:20 GMT -5
Here is the original post from YMB: oxotnik1 • 11 hours ago Flag 49 users liked this posts users disliked this posts 2 Reply This Friday, Dec 4th, SNY flying initial adopters to San Diego's Del Mar Hilton . for weekend meetings with scientists from SNY and UCSD. Topics include dosing and who knows what else. This would not be happening if SNY planned to drop MNKD. I will get updates and let all know next week. Afrezza user posted this comment on Twitter this AM: Afrezzauser afrezzauser · 1h1 hour ago On way to San Diego till Dec 6th! If anyone would like to meet I will try to do it. Send private message. #afrezza Who is going to go to San Diego and try to infiltrate the meeting and report their finding on here? |
|
|
|
Post by mindovermatter on Dec 1, 2015 20:09:26 GMT -5
Everything is falling into place for Sanofi to apply for EU approval. I Don't see any reason not to. The global rollout is like playing Chess. The U.S. pricing is the current benchmark for the rest of the world for Afrezza. The EU tends to have the lowest prices. Middle East would use the U.S. pricing benchmark unless AFREZZA was EU approved and then many countries would use the EU benchmark. Many countries only need FDA approval and SNY can start marketing. The sequence of country's rollout makes a difference in pricing for the world. Re: US as a benchmark for pricing. Might want to read this as to why the US is not a benchmark for pricing. The US is the only place where a drug firm can charge what ever it wants. www.wsj.com/articles/why-the-u-s-pays-more-than-other-countries-for-drugs-1448939481?mg=id-wsj |
|
!!!