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C20, I have learned quite a bit in the last couple weeks about treatment of covid related respiratory distress. But I've also seen how dedicated the doctors and nurses are who are dealing with this pandemic, and they are operating with a ton of pressure on their shoulders. Finally, the support and prayers we've received from strangers has been unreal. Anything I can do to help your friend Im happy to do. Keep the faith!
Yes, it did seem to be a somewhat convoluted process for us, and I'm pretty sure my wife was the first eind issued for LL since the trial filled, but I can't swear to that. Heres hoping it goes smoother for you. Im sure it helps if the doc involved has done an EIND before, and I'm not sure why wife's doctor has done one in the past.
FDA emergency approval dept is available 24/7, but they do have a special ph number for after hours and weekend access. I can give you the number if needed.
Dr. Kelly, you will find, is the BEST !!! Same for our CEO N. Pourhassan. Salt of the Earth, they both are.
My wife is not out of the woods but they are discussing an attempt to wean her off the vent maybe today or tomorrow. This could take up to three days they tell me, depending on how She does coming out of sedation.She was dosed with LL yesterday, I am almost certain. I was not able to get a hold of the particular doctor who was accessing the Leronlimab, but yesterday was supposed to be the day.
Again, I must say we are humbled by the hundreds of strangers who have prayed for my wife. We are truly blessed and I hope to have her back home in a week or so.
If you need anything regarding all this just let me know.
C20, I can probably add a little to this discussion since my wife's doc was just able to get an EIND for LL from the FDA. The whole process takes longer than you might expect, especially considering they're using the term 'emergency'.
1- you need to find a doctor who will even consider using a non approved drug.
2- that doc will then want to do some research on LL, at a time when these doctors are already badly overworked. This research may or may not include a conversation with the FDA.
3- the doc will need to get a 'letter of authorization' from Cytodyn to the FDA. Template available on FDA website. This tells the FDA that Cytodyn is on board, willing and able to provide the drug if they approve.
4- the doc then makes a formal request to FDA. In our case it was still 2 days from request to approval. This may speed up as they issue more but FDA will still want to access patients condition before approval, so there will be some time involved I believe.
5- if you get approval now they have to get the LL to you. Could be another day or 2 depending on a few factors.
In our case my wife stabilized her first couple days on the vent and then her lung function started improving. Her improvement made it easier to deal with these 'delays' in getting her the LL.
To answer your vent question, the conversation my doc had with FDA inferred that the shorter amount of time the patient is on a vent the more likely it will help the patient. No brainer. But the doc mentioned 2-3 weeks as a vent time frame that may indicate less chance of success. Hope this helps
Yes, that sounds more like it misiu.
Dr Jerry, just google Leronlimab, covid, EIND and you'll get a pretty decent breakdown of what happened with the first 55-60 EIND's that were authorized, this was at the beginning of the pandemic and before any trials.
When I've pointed out to friends that I'm getting by on 1 meal and a few hours of sleep a day, just like you Learning, they tell me I gotta eat and sleep. And of course, you are all correct. But I am finding out its not easy to force yourself to eat and damn near impossible to force yourself to sleep. But I appreciate the advice for sure.
No question about it.
Could not agree with you more, trading. Let's be honest about this. The severe/critical trial may or may not make us wealthy. But a single EIND for a 70 year old woman in a hospital bed in Fargo ND is not going to make anybody any money, whether it helps her or not. But I'm telling you right now, the execs at Cytodyn have put in an incredible amount of time and effort on her behalf. I am forever indebted to Dr.'s Pourhassan and Kelly. That's a fact.
Yes. To be honest, the first doctor I dealt with, one of the hospitalists, totally blew me off when I asked and begged for him to consider a non approved drug like ours. Since I don't give up easily I was able to get to the head of infectious diseases there, and this guy is superhuman, the amount of work he has done for a woman he doesn't know who showed up in his ICU and her persistent husband is unreal.
And thanks to all for the continued support and prayers. Sounding like the LL will be in Fargo tomorrow. These guys are unreal!!
Misiu, so sorry to hear that. It could have easily been my wife's situation, as you know she was really heading downhill fast as well. I saw her o2 sats in the low 80's, which is scary enough.
To get the Leronlimab, or any investigational drug, you really need a doctor willing to do a ton of work, and we are blessed that the head of infectious diseases here has been willing to do all this for us. Likewise, Dr.'s NP and Kelly have been unbelievable!
Thank you for the prayers and kind words.
To all- it took 2 days and many discussions with my wife's doctor, but the FDA came through for us on our EIND request !! I hope to have the LL in Fargo tomorrow.
The FDA's thinking being that since she's only been intubated a few days Leronlimab may have some benefit for her, and at the very least, the safety data indicates it will not harm her. She's holding her own still on the vent.
Thanks for all the prayers and please keep praying for her.
Is anybody here familiar with the expanded access program for aviptadil? My wife is on a vent in Fargo ND, closest hospital participating in expanded access for this drug is 500 miles away in Nebraska. Anybody know if they send the drug to hospitals not already in the program? They don't answer the phone and don't return voicemails, so all you can do is leave a message on the website and hope for the best.
Misiu. Thank you. I would instruct your friend to jump on it regarding the LL. Some people deteriorate very quickly with covid, as my wife did. She went from home oxygen to high flow oxygen to Bipap to vent, and this happened very quickly, a matter of a few days.
She is on Remdisivir and methylpredisone and an antibiotic right now. Her Doctor has spent a ton of time with me. He investigated Leronlimab and Aviptadil for me for possible use. He's ok with LL because he believes it is safe. But he told me, honestly I believe, that if the patient was his wife he would continue the normal standard of care without the LL, because most people are surviving on the current regimen. But he will give her our drug if FDA oks it. Thanks for your concern.
Thanks again to all. Really if you haven't dealt with Dr 's Pourhassan and Kelly you cannot imagine how much they care about helping people like my wife. The FDA now requires a 'letter of authorization' from the drug manufacturer to even consider an EIND request. They want to know the drug company is on board, willing and able to provide the drug if they approve the request. With the help of Dr.'s P and Kelly we were able to get that letter to FDA yesterday. I know for a fact they had the lawyers and our CRO involved in an effort to get this letter right. You can't believe how much work has been done on behalf of my wife. Her Doctor is doing the formal request today.
To all who prayed for my wife, she is holding her own her first day on the vent. The next couple days are quite important for us. I'm still trying to get her some LL. Lots of red tape, but her doctor in Fargo and Dr.'s NP and Kelly are all going way above and beyond in our quest to get this drug to my sweetheart. They're all devoting lots of time to this. Truly impressive.
Please pray for her over the weekend. Thanks to all.
I totally agree. And thanks to all for the kind words and prayers.
I do as well. Scott Kelly called me himself today and reached out to her doctors at Sanford Health. Both doctors Pourhassan and Kelly jumped right on this to try and help her.
Our thanks to everyone for the prayers and concern.
Please everyone say a prayer for my wife. She's not in good shape right now but I did want to report that Dr. Pourhassan and Dr. Kelly are going out of their way to try and get her some Leronlimab for her via an EIND.
Taking a long term view, is there any reason I wouldn't want to pick a few more shares up at .67 ??
Yeah i see that finally. Yeah their timing sucks.
What the hell happened after hours?
In not sure where you're coming from. If you're staring the end right in the face, you'd be thrilled to be given another 3 to 6 months. That's the sad reality of many metastatic cancers
You guys have any explanation for all the odd price movements in the after and pre markets? Seems pretty odd
Theres plenty of underwear clad day traders who are apparently happy to make a few pennies on this thing, my evidence being the couple 100,000 share trades in the last little while. Best of luck to them. That's why most traders go broke.
I got a lousy 141 share fill at .78 today.
Was hoping for 1000
We up to 95 cents in after market. Something going on ?
Unfortunately was not me
I have a constant buy order in at .78 now.
If it gets filled I add a new one. Seems to be working pretty well for the time being. I've gotten a bunch filled
If is was simply an antiquated process, that would be bad enough. But this FDA is corrupt to the core. All the tiny companies trying to get covid drugs approved should just hire a stinking lobbyist and start greasing palms already, forget about this pie in the sky helping the patient BS. Money talks in the swamp.
This thing went from 90 cents to 80 cents in what, 20 minutes? Crazy shit
Based on the chart pattern, 2 high vol up days followed by a flag/pennant formation, next move up if we do break out is to about a buck. TA doesn't always work with these penny stocks though.
I can see that. I tried to pick some up at .78 this afternoon but unsuccessful. Left the order open though
Seems like, with the market cap so small, most people agents giving the CE Mark much value.
What did they have to do to get the CE Mark? Were there clinical trials involved or is it just a matter of the product not harming anybody and you get the CE?
Thanks for that. Finally had a half hour to check it out, that's a pretty impressive presentation. Im still adding under 80 cents. Seems like the share price does mice nicely on news.
Have you got a link to that virtual presentation?
I shall. Thanks
I might get my .80's filled yet. Dipped down to 82 cents earlier