This is the first time I've heard of yet another challenge diabetics have in their daily lives, not only does mealtime present a challenging event but exercising. Now that you have pointed it out, Afrezza goes even beyond the high opinion I held of it being the best medical drug/device that I thought it was, that it can also serve to balance your body's response to heavy exercise. Your testimony at Adcomm and continued posting here is so appreciated, we like you hope there are no delays in the launch so you can resume your use of this life changing product.
Riley wanted this in place before anything further could happen. Now SYN is running on solid ground with new track shoes and is the crowd favorite!
Wow, so much good news from your exams! You should set up a blog, while we can't thank you enough for sharing on the YMB, unless you are posting to a blog, your progress can't be seen by as many people. I don't know if you are under any restrictions while in this trial, so be sure not to run afoul of those if any. Have you been in touch with the people at SYN to let them know of your progress? You are very articulate, and we are thrilled to hear from you. Continued good results to your health!
I've seen this before, when a company is near to a deal, they hesitate to present where questions could be asked that they cannot answer without causing a new round of speculation. Given the blackout on news from either SNY or MNKD corporate, it would stand to reason that they're in talks of a very serious nature.
Posted today by Vaqueel (repost). "from a friend that works in MNKD Danbury plant... all workers were briefed on not answering any questions about afrezza outside.. But all three lines are in full operation and there still exists three shifts that continue to package Afrezza...he said they are making afrezza in large amounts and everyone there is full of energy and have so much enthusiasm ... Less"
We love it when real people, who suffer from diabetes, post their stories on our message board! How many diabetics will you share your news with? Please continue to post your experiences here, and we wish you the very best with your health! If you are on Twitter, do like @afrezzauser does, check him out! Good luck!
But somebody dumped ~65,000 shares into the first 5 minutes today, and another ~70,000 shares into the third five minutes of the day. There wasn't sufficient consistent buying volume over the course of the day to bouy the stock, and no end of day buyer. At 1 pm ET we had a 20K+ buyer who pushed the price back to 1.57, but that faded into the ensuing periods pretty quickly. Anyone get the feeling that we are basing out in here around $1.50?
I thought I would share the update I wrote for one of my friends that I turned on to Cytosorbents.
It has been an eventful month. On the financial side things are falling into place for growth. In December they did a reverse split to meet the share price requirements for up-listing to the Nasdaq capital markets and up-listed. They also reduced the authorized shares to 50 million. They also just completed a follow-on-offering of 1.25 million shares at $8.25 to raise about 10 million dollars, after costs, to fund marketing, more studies and increase manufacturing capacity. The follow-on offering prospectus also included a clause that allowed the underwriters to manipulated the stock price for stability during the process of the offering. I think that is why there was a price drop and it has stayed near the offering price. With the offering, the total outstanding shares is just about 25.5 million. Add in authorized warrants and option, the fully diluted share count is at about 27.7 million. With just under 5 million shares owned by one venture capital company linked the Cytosorbent’s founders the float is at about 23 million. That is not a lot of shares once things gain momentum.
I am fairly certain Cytosorbents has quite a bit of good PR they want to release, but according to the company they are in a “quiet period” as part of the offering. Nasdaq says that period ends on 2/8/2015, so I don’t expect much news or PR to start flowing until after that time.
One the regulatory side of things, they submitted an Investigational Device Exemption (IDE) application to the FDA on 12/30/2014. I’m not sure how familiar you are with the regulatory process, so I will share my research with you. With an IDE approval the company will be able to conduct a phase 3 pivotal cardiac surgery trial. When an IDE application is submitted the FDA sends a letter to the company acknowledging they received the application. That starts a 30 day clock running. In that 30 days the FDA can deny the application approve the application, request more information or data or not respond at all. No response is equivalent to an approval. Cytosorbents has been in constant communication with the FDA for years so I am pretty confident that at this point the IDE approval is almost a formality. Once the IDE is approved we can expect Cytosorbents to announce the planned start of the pivotal cardiac trial and get a better idea of the trial protocol. From my research and review of their August 2014 presentation, the IDE application PR and the recent OneMedForum presentation I think there are clues to what regulatory path they are planning to take. The August presentation listed 3 possible FDA regulatory approval pathways:
1. 501(k) – Cytosorb used intra-operatively during cardiac surgery with a primary outcome measure of reduced pro-inflammatory biomarkers
2. PMA (Pre Marketing Approval) – Cytosorb used intra-operatively during cardiac surgery with a primary outcome measure of reduced organ dysfunction
3. PMA (Pre Marketing Approval) – Cytosorb used post-operatively during cardiac surgery with a primary outcome measure of reduced organ dysfunction
If Cytosorb is classified a class 3 device they will have to go through one of the PMA paths. The PMA route is more rigorous and requires a larger study and more time. As I understand it class 3 devices are usually implantable devices, so I think Cytosorb will be a class 2. Class 2 devices can go through the 510(k) process instead of PMA if there is a substantially equivalent predicate device already approved or cleared by the FDA. Note that 510(k) results in a device that is “cleared” for marketing while PMA results in a device that is “Approved” for marketing. Not sure what the difference is. There has been some speculation among a group I talk with about Cytosorb that there may be an approved Leukoreduction filter that may qualify as a substantially equivalent predicate device for Cytosorb. Now take note that the IDE PR and OneMedForum presentation both mentioned “Intra-operative use of CytoSorb® represents an innovative new strategy to improve the safety of complex cardiac surgical cases, and to reduce inflammation generated during the surgery”. There was no specific mention of reduction in organ dysfunction, although that is obviously the ultimate goal. This leads me to believe they are looking for a primary outcome of reduced pro-inflammatory biomarkers, the 510(k) path. If they do go the 510(k) path I hope one of the secondary outcome measures is reduced organ dysfunction though. Also note that in the August presentation they specifically stated that regulatory path they choose would be decided based on feedback from the FDA, so the path they take will already have the FDA’s blessing.
The August 2014 presentation also said the 510(k) path would require a study of less than 150 patients. Couple this with the fact that Cytosorbents has MD’s on their cardiac advisory board that are from a number of large US university hospitals could lead to a trial that enrolls fairly quickly. If they choose to also use EU trial sites it could enroll very quickly as the device is actually approved in the EU, not experimental, and it has already been used on over 100 cardiac patients there.
The US cardiac trial will have a primary outcome measure of reduced pro-inflammatory biomarkers. The EU study that got Cytosorb CE mark approval in Europe had a similar primary outcome measure. There have also already been over 3500 human treatments with Cytosorb and the data from many of these has been collected in the International Cytosorb Registry database. Many pivotal FDA studies only have limited phase1 and phase 2 study data that can use to design the phase 3 study on. Cytosorbents however, has a large amount of data to base their pivotal study design on, which means they will go into it with a higher probability of success.
One Key opinion leader, Frank Born, the Head of the Perfusion Services, Department of Cardiac Surgery University Hospital Munich-Grosshadern, Germany stated in regard to Cytosorb "I can imagine this therapy will become established as the standard care in cardiac surgery and repeat cardiac surgical procedures in the next few years." That is a pretty powerful statement from someone who is using the device regularly. Also note that I think this quote is over a year old.
I think we will have the following upcoming catalysts to look forward to:
1. Q4 2014 sales results and shareholder letter
2. IDE approval
3. Start of Pivotal US cardiac trial
4. Announcement of a partner for the US cardiac study. They may go it alone, but a partner would be a big boost to ramp up sales and distribution quickly in the US if approved.
5. Marketing approval and start of sales in the 6 EU countries where Fresenius is their distribution partner. The contract with them states they must secure this approval within 6 months
6. Announcement of a pediatric version of Cytosorb. There are hints to this in development on the Cytosorb Registry web site.
7. Results of the US Air Force study on the use of Cytosorb for Rhabdomyolysis
8. Results of the EU cardiac study
9. Result of the EU dosing study. This has been going on for over a year at 8 trial sites
10. Announcement of the name of the top 4 cardiac company that is evaluating Cytosorb in France and a possible partnership. Rumor is that it may the Sorin Group.
11. Result of any of the other 40 + investigator initiated studies in the EU.
12. Licensing or possible partnership for the Hemodefend product.
13. Results of the ABLE study, hopefully supporting the need for a product like Hemodefend
14. Updates on other pipeline products: ContrastSorb, DrugSorb and BetaSorb
15. Update in the SBIR contract with the US army for burn treatment
16. Update on the DARPA contract
Someone put up 20,000 shares on the ask at .43 this morning, and I hit their ask and didn't have to dicker around to see if I'd get a fill or not. Whoever sold to me, thank you. Last time I made a 40% trade in a couple weeks when I purchased at .40. This time I plan to hold for the longer term gains.
And that is only the beginning of profitability for IGXT who has differentiated itself by developing the Versafilm technology and building their own manufacturing plant so they can also make profits manufacturing for others, rather than sharing what they know to third party manufacturers. Horst will see this all the way through, he's determined and the right one to do it.
It has nothing to do with our stock or where we are in our trials, it has everything to do with what is happening across the board in biotech today, after yesterday's fiasco with ABBV making a deal with Express Scripts, they're now only covering the one drug for Hep C, Gild and sector loses, ABBV gets covered with their treatment.
Since the 'Kanzer dump' back in April, we've had a 10-month 'descending' triangle forming on the daily and weekly charts. Descending triangles technically have their bottom line horizontal, yet this bottom line is rising, therefore it's more of a falling wedge than a descending triangle. To see it, draw a line from the April 2013 high down through this weeks close, connecting the highs (cut straight through the overshoot highs of late August and early September). Doing the same along the weekly (or daily) lows. This gives you a down sloping triangle pattern that is coming to its apex in the next two weeks. Price movement is compressing with the end of the wedge closing down at its apex. Daily moves are nearly touching both the bottom and top of the wedge. Today we closed on the top line of the wedge 1.58. On the daily, during the last 10 trading sessions, we have touched this upper triangle line 8 out of 10 times! Given today's close on the line, we could see this consolidation pattern end in a dramatic up move, or breakout. I am not going to predict because I don't know, but accompanied by volume (if news) would make for a dramatic move. If nothing happens next week the wedge has about another week before this pattern plays out. I'd give it 70% odds of it happening without news, and 100% if we get positive news on SYN-004 efficacy results of Phase 1b. Thoughts?
Sentiment: Strong Buy
I'll say we get to $4.50 with a Trimesta partnership, and $3.10 with a positive Syn-004 phase 1b efficacy report. Without either, something positive may get as us as high as $2.25.
Would 3 cents up be a start on the move? I'll take the three cents and wait for the rest to come before the end of the month. Hard to pinpoint these things, fun to guess though. Thanks for the entertainment.
Mike, you've prepared us for this day, good call, and congrats to all longs for making it to this day!
It's one thing to be nominated, quite another to WIN it. This speaks volumes, purely an investor conference, now word is getting out and others are learning what we've known here for quite some time. They won't be able to get enough of it, shares are headed much higher.
That you could just go away? I don't get it. OK, regardless, your presence will be surely missed! I've seen pronouncements like this before by others, it's a hard thing to do to your fellows, but if you have a higher calling and just want to give it a rest, take the break, but know you're welcome back anytime. If this is a hard and fast decision, then may your path be paved with inspiration and happiness. Don't think for a minute that coming back to post again will be viewed as going back on your word. We would welcome a change of heart, you have friends here, that is what makes it hard to understand why you feel you must leave? Good luck PB, Geri, and I hope we see you back. Jr.
Wow, a long poster! We have such a drought here. We will win if we persist. I am investing more elsewhere now, but have 50,000 shares here that will pay me well one day. Here's to hope, and accomplishment!