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You sure about that? You know were 2 reverse splits during that period, right?
You are confused. My source didn't convince me to stay with the stock - I never said that. He only helped me understand an issue with the manufacturing facility. That was all.
The people on this forum deserve better than to endure your misconstrued inferences. I am going to Ignore you so I won't see any more of your posts. That should eliminate ridiculous exchanges like this. All the best.
Your question makes no sense.
It has nothing to do with keeping anyone out of trouble. I thought using the word "source" would be too vague. Every statement has a source, right? But in this case my trusted source is someone I have been communicating with for over 2 years (it's not Geert). I know this source well enough that when he says something I don't question it's validity, hence trusted.
Hang on. I never said I emailed Geert for that information. I received it form someone else, who I trust. The "waiting on parts" issue is perfectly inline with the global supply issues of the last 2 years.
If anyone has any questions, I recommend calling Gavin in IR.
I agree that handling it now is better than after the pre-BLA meeting. But I wish they didn't need to submit a "major follow-up packet" to the FDA. Maybe this is nothing and just part of the process with a new class of drug. But considering we are 15 months out and no pre-BLA meeting scheduled, I am concerned there is a bogeyman in the data somewhere. Regardless, I am still optimistic and the SH letter is a big reason for that.
Remember, when CVM announced their results, their first step was to reach out to the FDA and request a pre-BLA meeting. These are their words, not mine. That was in July of 2021. We still aren't there.
CVM will succeed with the data...or fail with the data. As Geert has always said, the data is key. I do want them to succeed...I really do. But I have to recognize this 15 month timeline to a pre-BLA meeting (and we're still not there) does not seem normal.
Sushi is correct that the FDA is holding up the BLA submission. They want some answers first before they will accept a BLA. That much can be inferred from the letter.
Questions from the FDA are normal. But the answers to those questions would typically be seen in the data from a quickly forthcoming BLA.
Questions that must be answered before a BLA is accepted is not normal. It is still an uphill climb for CVM.
What there any mention of a pre-BLA meeting with the FDA?
You are 100% correct.
Early 2024 for approval (at the earliest).
I am not.
You are correct. Data submission to clinicaltrials.gov is (sort of) optional and has no bearing on regulatory filings.
Coverage of ALNA on Frugalnorwegian.com
https://frugalnorwegian.com/alna
All the best.
New 11/1/21 Podcast with Dr. Eyal Talor - "A Promising Treatment Option for Patients Diagnosed with Head-and-neck Cancer" - Dr. Talor reveals insights about Multikine not previously disclosed (to the best of my knowledge).
https://www.spreaker.com/user/7078249/tob-full-show-89-eyal-talor-multikine-cel-sci
1. They’re going to try to announce a bla update and the peer review either concurrently or right after each other so the shorts can’t say anything bad about the peer article. In other words, if the bla makes progress, then any Data must show sufficient option for submitting for approval, the preset data submission is legitimized
I had hoped they would have announced the feedback from the pre-BLA meeting, but I don't think they will do that any more. I suspect that meeting has already happened and since we haven't heard anything, we most likely won't. Geert doesn't care about the shorts for the time being. He doesn't need to raise money until 2023 so the short-term SP is irrelevant. We should have some sort of positive catalyst before money is needed.
2. The buyout could be silent and may have already happened. The big company does this so to avoid bad PR if the approval doesn’t go through
No. Once a buyer and seller have agreed on terms, there is no need to wait. An announcement would be forthcoming. Instead of being quiet if an approval doesn't go through, a BP would just wait to make an offer until after a BLA acceptance announcement. BP would rather pay a lot of money for an approved drug vs. take a risk on a drug that might not make it through approval. Also, just because a company receives a CRL, doesn't mean the drug is finished. The sponsor often fixes the errors (as long as it's not trial related) and resubmits.
Most likely the previous HR person took another job.
CVM is mentioned at 25 seconds on lightning round.
https://www.cnbc.com/video/2021/10/18/cramers-lightning-round-i-prefer-intuit-over-mogo.html
Just saw this. Thank you!
Article highlights two more trials that bit the dust in Head & Neck Cancer, when assessing overall survival. Multikine did something truly amazing, which is clearly not well understood by the market.
But it will be!
https://www.fiercepharma.com/pharma/bristol-myers-opdivo-yervoy-pfizer-merck-kgaa-s-bavencio-hit-walls-head-and-neck-cancer
Here is an interesting bullish take on CVM.
https://www.tradingview.com/chart/CVM/B8quaLAp-CVM-and-Multikine-Rating-and-Confidence-Reaffirmed/
Brand new Reddit forum discussion TRVI.
https://www.reddit.com/r/TRVI_Stock/
New reddit NXPI forum to exchange ideas and DD.
https://reddit.com/r/NXPI_Stock/
Hey...I did not do the article. This company has dropped off my radar. I am now focusing on biotechs. See my page: https://frugalnorwegian.com
By the way, I don't have a paid account so I am not able to reply to you privately.
If you are new to NMTR, go here: https://frugalnorwegian.com/nmtr/
- All information on 1 page
- Catalyst countdown timer
- several videos to watch
- provides a high level summary, and goes deep into the clinical trial success chances
Here is the most recent presentation by 9 Meters (Aug 12, 2021)
https://bmo.qumucloud.com/view/2021-biopharma-9meters#/
342 members on Reddit to discuss NMTR
https://www.reddit.com/r/NMTR_Stock/
The company does a great job keeping their presentation up to date! Check it out.
https://9meters.com/assets/docs/9Meters_Corporate_Deck.pdf
Today was a great day! Still highly undervalued with a Phase 2 and Phase 3 drug in clinical trials.
New reddit group talking only about ETTX.
https://reddit.com/r/ETTX_Stock
New webpage on CAPR for those interested.
https://frugalnorwegian.com/capr
Latest article by Andy - CEL-SCI : FDA's Recent Subgroup Cases Point to Multikine Approval
https://www.cvmresearch.com/p/cel-sci-cvm-fdas-recent-subgroup
New community for additional DD on ALNA:
https://www.reddit.com/r/ALNA_Stock/
Here is the latest gem by Andy!!
I highly recommend subscribing to his articles, if you haven't already.
https://www.cvmresearch.com/p/cel-sci-cvm-pre-bla-meeting-the-next
Agreed, their PT aren't worth very much from analysts.
Thanks for your input on this board?
Sorry for my lack of clarification. There was a previous DJ document from May, I think. Did that earlier document have the same verbiage about 'looking for a partner'?
A lot of biotechs are looking for partners so I didn't know it might be standard verbiage on these docs.
Diana,
Did the previous Dawson James coverage document have the same phrase?
According to a recent PR, the company has cash until 2023. There should not be dilution for a while.
You are correct. A successful P3 trail is critical for the SP.