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I’d be happy with licensing too - we’d still all be fat and happy - no diabetes pun intended - lol
Not a financial person but with a 2017 $66B developed world diabetes market, growing astronomically every year - I would be surprised to see this go for under $10 per share. Diabetes encapsulated treatment is the holy grail these days....just my opinion.
Something I want to say is the best days I’ve had at work over the years are the ones when patients come to visit and they tell you because of what you do every day their life has been changed or saved.
Agree. If you’re going to be bought by big pharma upon reaching your IND milestone you don’t need a CRO.....
To clarify- in my opinion Eurofins is best of best. I expect no issues with MCB on their part.
Testing during and after production confirms nothing was introduced during production. No impact to MCB that has already passed testing.
They would also test the product for predefined attributes that the company has identified as indicators of product quality and consistency - product that fails any of these is highly unlikely to be released for use. But they would have already validated (performed 3-5 batches showing they routinely meet this criteria) before making clinical material to put in people- all just my opinion. Hope this helps.
No bad vibes intended tbone - have worked for a biotech that got a virus from bovine serum that wasn’t irradiated- production had to be shutdown and the whole building had to be evacuated and decontaminated - then we spent a week cleaning up the residue from the decontamination - it’s awful - just sharing why Eurofins would not accept our cells without virus free confirmation for our cells.
No bio company wants a virus shipped to their lab. It’s a major decontamination job if they do. That’s why the cells had to be certified virus free before shipping. Maybe austrianova isn’t fully certified yet for MCB production? All just my opinion.
I may have remembered the patient number wrong - sorry. They could easily make a 1000 vial batch to cover all.
Eurofins required us to test the cells before shipping to them.
My opinion only - not something I have done but my guess is that they would have isolated the cells they wanted then grew them in media (cell food) to a harvestable volume.
Every batch of product goes through release testing to confirm product quality before it can be used.
A vial or two of the MCB are typically used to grow a Working cell bank - say 400 vials that you freeze - then you thaw and use a vial or two of your working cell bank to grow a batch of product. A batch of product can be used to create anywhere from hundreds to thousands of vials of product depending on how big your process is - some biotech’s have 20,000 liter bioreactors. This means your MCB will last for many years.
....after encapsulation about a week to lyophilize (freeze dry) vials - I’m guessing 500vial batch since they only need to enroll 100 patients.
I agree Pink! Growing and encapsulating a couple weeks then batch release/testing - we should be filed by end Feb-March.
Also have seen concern on the board of using the MCB for trials - please keep in mind that even a typical MCB will have at least 400 vials and it only takes 1-3 vials to grow the entire batch to make all of the clinical material- very smart move on PMCBs part to skip the WCB.
Good luck everyone.
Just my opinion
Everything that was talked about today is something I have experienced in 30+in biotech - IMO things are fine just not as fast as all of us including me would like. Eurofins is THE place to make cell banks. I’m holding all my shares.
Sorry this took so long- my internet was down due to storms. I haven’t made cell banks but I know some of the testing takes 7 weeks. The length of time to grow the cells varies with batch size but it wouldn’t be unreasonable for it to take 3 months to produce both banks . If they start the working bank while the master is under test they could save a little time, but that is risky and expensive if the master bank fails any tests - they’d have to scrap them and start over. Not likely as Eurofins is the best in the business.
123 appreciate your posts
Do want to provide my thoughts on the 640k to austrianova- this money is for encapsulating the cells Eurofins is growing. The cell banks are just cells that can be grown from the 2 ml vial to a larger volume anywhere from hundreds of liters to thousand in a bioreactor - then encapsulated with the cellulose by austrianova- cell banks are not encapsulated yet - to support this opinion I will say I’ve been working in biotech for more than 30 years. Hang in there we will reap benefits for our patience.
To get a better understanding of how much work goes into the cell bank preparation, the link is a presentation from Eurofins
Thanks
I couldn’t get an answer when I asked
Thanks - saw that and cleaned up the post
Contacted IR this is their response
Thank you for your email and for your interest in PharmaCyte Biotech. There are no timelines being given out by the company because the company is waiting itself for a timeline to offer the public, so in a word, no, this is not something the company has said.
Thank you again for your email and for your interest in PharmaCyte.
Investor Relations
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Thanks Triple!
PMCB is still listed on FDA significantly regulated organizations (SRO) list published 05 Sep 2017. Not sure when we were added.
https://www.fda.gov/aboutfda/workingatfda/ethics/ucm079670.htm
Agree!
Both company FB sites were reduced to a couple postings - all other history gone. I take that as a good sign things are in play for partner or buyouts.
Austrianova and pharmacyte FB posts have been stripped down - get ready for the fun fellow longs!