IMHO taking out a lot of stops. Kicking myself for now having one. A lot of money has been made here in a very short period of time. If it reaches five, IMHO the risk/reward ratio is in longs favor with my downside risk at 2 and minimal upside at 9.
Two weeks after enrollment completion, the trial should be done... right? So that puts us at around Feb 7.... then 15 - 30 days to analyze data... so IMHO that puts results between Feb 22 and Mar 14.
Results could be published in two weeks. I give this thing a 98% chance of good results, given the large phase IIIA trial and especially since the drug has been prescribed for who knows how long previously as a concoction compounded at your pharmacy. I need to listen again to the CC where mgmt. was asked about the market for the drug. I do remember them saying that stats are not kept on compounded prescriptions, but don't remember what their estimate was. I'll be quite happy if we get to 5... holding 30K shares at 3.
Notice they all bought right after the MM-398 trial extension was announced so no conflict... but you know they saw real data that led them to estimate the trial wouldn't end until Q2. It must have been REALLY good for the execs to scoop up 500K shares.
IMHO, it's nearly impossible for insiders to not trade on insider info... seems an oxymoron because they are inside the company. There are always things going on inside a company that aren't public.
It's way too early to even consider hearing news. Mgmt said Q2.
When April 1 arrives, then the real conversation begins. I expect we won't hear anything until at least May at the earliest. Another poster corrected my misconception that this trial was blind.. it's open label... so that makes the insider buying that much more of a validation how good things must be going... since they have access to the ongoing data (at least in some form). So I would take mgmt. at their word... no news until Q2.
VTUS is a slam dunk... APPY running a close second. I'm holding both. Both sold off, but my more speculative plays (NBS, MACK, MNKD) got hit harder than either VTUS or APPY.
However NBS,MACK,MNKD all have giant upside potential.
Or it's a block trade reported from a dark pool at EOD. Look where it's being reported from. If it's Nasdaq TRF then it's likely a dark pool... typically meaning institutional trading large blocks among themselves. Search for dark pool trade reporting.
Seems you'd do a whole lot better in SDIV. Given the strategies are similar, wonder why such a big difference (SDIV paying out at least 6% after expenses).
Here's a bit from the post 171/175 study CC. Anyway, this is the MACK board. There are plenty of pro/con arguments over on the MNKD board.
Okay. And, I guess, turning to the cough, you provided some color on it. And I was just wondering if you could maybe expand a little bit on the -- what was sort of the reason as it relates to cough for dropping out.
Yes, if you remember, the dropping out due to cough was an insignificant component of the 5% who left the study in those receiving aspart, especially in the type 2s, whereas only 1.9% of the control dropped. What I can tell you is that if you go back and look, I mean, cough essentially was a nonevent in the 171 study in type 1s because the comparator -- I mean, I think they had 4 reported cases total. So we saw a significant incidence of cough compared to insulin aspart in type 1. The cough incidence in type 2, where we're comparing AFREZZA-Gen2 to the placebo, was essentially comparable between the 2.
Just curious what you don't like about Afrezza? The latest trial met all its endpoints, although the market was disappointed in the A1c level comparison between injectable and Afrezza. Given Exhubera has already been approved, seems like Afrezza has a good chance, especially given that it's superior to Exhubera. Only real thorn is the transient cough... but a few patients have now been inhaling Afrezza for years with no major issues (those granted compassionate continuance to use the drug). MNKD has years of data to prove safety from previous trials and this latest trial met endpoints allowing all medtone inhaler safety data to be applied to the dreamboat trials. Afrezza has been used by almost 5000 subjects so far. Most skeptics are using the argument that MNKD has not released all of the data (they haven't) and has been selective about what they publish. Only MNKD mgmt knows that answer.
Biggest downside I see is no partner and lack of cash. That could spell real trouble even if Afrezza is approved.
The near term catalyst is not here... it is the Baxter trial. I can't determine exactly when results should be reported, but it could be anytime. If the Baxter trial results are good, that is a screaming buy signal for NBS.
I'm about to retire at age 57 and am planning on buying 1M in high yield dividend ETFs. I've started with DWX, SDIV, LVL. FYLD is the next on my target list, after I unwind from positions in biotech stocks. I'm keeping a few hundred thousand $$$ on the side for active trading, but I need a reliable income generating base. I'm seeing around 5.5% average yield from DWS, SDIV, LVL. I need about 40K before taxes to live on.
What ETFs are you holding? Have you been successful in creating a reliable income stream from your dividend yielding ETFs?
Here was the question and vote summary:
Questions to the Committee:
1. Efficacy in type 1 diabetes: Is there sufficient clinical trial evidence that Exubera® can be effectively applied to an “intensive” glycemic control regimen?
YES: 8 NO: 1
2. Efficacy in type 2 diabetes: Has the efficacy of Exubera® been adequately assessed in patients with Type 2 diabetes?
YES: 9 NO: 0
3. Hypoglycemia: Has the safety of Exubera® regarding hypoglycemia been adequately assessed? a. In Type 1 diabetes in “intensive” control regimens?
YES: 7 NO: 2
b. In Type 2 diabetes?
YES: 9 NO: 0
4. Pulmonary effects: a. Are there sufficient data to assess the pulmonary safety of Exubera® in patients without underlying lung disease?
YES: 9 NO: 0
Endocrinologic and Metabolic Drugs Advisory Committee Meeting September 8, 2005 NDA 21-868 Exubera® FINAL MINUTES
... do the data suggest an acceptable pulmonary safety profile in patients without underlying lung disease?
YES: 9 NO: 0
b. Are there sufficient data to assess the pulmonary safety of Exubera® in patients with underlying lung disease?
YES: 4 NO:
6. Should Exubera® be approved for the proposed indications? a. Type 1 diabetes
YES: 7 NO: 2
b. Type 2 diabetes as monotherapy, in combination with basal insulin, in combination with oral agents
YES: 7 NO: 2
I held ARNA with trepidation through ADCOM and made over 200K selling on the subsequent run-up. I think ARNA had a lot of open issues going into ADCOM. Benlysta was a completely novel drug.
I think Afrezza has a much better chance than Benlysta did. Like it or not, we have Exubera on our side and insulin is ancient history. It would seem a bit embarrassing if the safety of insulin inhalation became an excuse to derail Afrezza, when Exubera is already approved. I think ADCOM will be focused a lot on the type II indication and post-approval REMS. The more I think about it, the more I believe I should hold through this ADCOM. If the panel has a strong affirmative vote, the stock will quickly price in approval. There won't be any approval pop in price.
I think if you check his record, there's a good chance a drug gets approved if he says it will. You gotta figure it's worse to lose money than to miss an opportunity. So he seems to play it safe and just bet against most drugs seeking approval.
He was wrong big time on DVAX. He was really pumping that one. They won't have results from their new trial until late 2015 and I've still seen articles from The Street recommending to buy now. Seems a bit early to start pumping it, so it makes you wonder. DVAX will be on my radar in a year.
KERX's second drug was not an oncology drug, so it doesn't count. Adam F had always said KERX's second drug would be approved. However he has stuck to his opinion that there will be no market for it due to generic competition and the nature of Medicaid reimbursement.