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Two weeks to grow cells then a month of testing - or possibly more because every product can have its own unique set of tests that define its quality-and that info is never public. Depending on how many quality assurance people they have reviewing the paperwork and the pressures applied by management to approve all the records quickly - 2-4 weeks more. I’m thinking end of July at this point. Jmo
Takes a month to produce the clinical material per one of their prs. Sterility testing takes 2 weeks post production- functional tests would be on syringes and packaging- those are simple pass or fail tests done in a day maybe two...I’m thinking July is IND filing.....
Thank you for sharing Newgene - sorry your friend had to suffer so horribly.
The testing timelines I posted are the ones I know. Samples are routinely collected throughout all production phases of a batch and all need to meet acceptance criteria for a batch to be released. The criteria is predefined by the company for product specific indicators of purity and product quality- and the usual agency requirements of sterility and contaminate free product also apply- it does take in my experience 2-4 weeks to release a batch depending on tests required.
Here is a link with a table of testing timelines for what it’s worth.
http://www.biopharminternational.com/mastering-cell-bank-production
I really don’t know why we haven’t heard anything. Just trying to be patient and still holding all my shares.
I’m surprised we haven’t heard about mycoplasma and sterility results yet- I’m hoping it’s because they’re moving forward with a partner or buyer agreement that involves their public silence. Let’s hope.
I think the company is fine and I’m not selling a single share but I do think shareholders are owed more information.
If what we were told previously was true and sterility and mycoplasma testing passed they should have imo - but apparently we don’t have all the information.
I’m not familiar with that- but like all of you I am disappointed by the murky later this year IND statement- not what previous information indicated. But I’m still all in for the duration.
I think all of that is entirely possible. I think Dr Sher with her extensive trial experience called all the shots here to give us the best chance of IND approval.
Well said 1234!
Imo when Dr Sher and Hidalgo et al looked at the preparations for trial they saw pivotal trial as risky but 2b trial as highly likely to be accepted by FDA. We still get our chance to prove our platform is game changing. If ciab performs as expected possibly better with improved encapsulation and continuous doses FDA can designate us breakthrough and we’re out there helping save lives.
You should be able to find that PR in their archives if you have time to check.
If I remember correctly the cells they used for the original studies were not identical and they hired a lab to separate the variants and produce a line with identical cells that they used to produce the current MCB. They didn’t know they had variations in the cell line when they put that PR out.
I don’t know 1234 but it is possible that the partner or buyer already has their own.
My thoughts....
Upon receipt of the vials they will thaw and grow them to I’m guessing 7-10L batch - perform the encapsulation reaction (longest reaction step I’ve seen is 24 hours) allow the cells to grow for a known amount of time to fill the ciab, then take samples for mycoplasma and sterility. They can then fill syringes and lyophilize (freeze dry) the product in parallel to that testing. The functional testing they talked about I’m guessing is taking sample syringes and testing that they work properly after freeze drying and maybe testing the syringe packaging integrity. Then if all passes file ind and ship to PMCB for trial prep. Jmo.
Imo if they ship to austrianova by end of February we should still be on track for ind file by end of March maybe very early April.
Then they can ship some of the vials to austrianova for clinical material production.
We should have mycoplasma and sterility testing complete end of this week early next.....
Sorry longboarder autotype changed your name lol...
Any more visitors longboards?
Good morning 1234
I think the buyer wants to see FDA approve IND because it makes the platform marketable. I think our buyers want ciab, pc treatment is icing on the cake. Imagine all the different targeted treatments you can put in an FDA approved box!
Morning all
Not worried about Melligen setbacks - if a buyer or partner has a cell line that only needs encapsulation...and we did secure rights to use all types of cells in ciab.......we are still very valuable because that big fish can use the combo to own the diabetes market worldwide. All imo
I agree 1234 and rayla- I believe in this tech 100% as a gamechanger but I too have only invested what I’m willing to lose- good luck everyone!
Jmo- I think the company has every intention of being filed in March. I also like esusuns post on activities- I think it’s reasonable that they have someone in the wings expecting them to hit this milestone- and ready to reward for that.
Happy New Year to you as well!
PMCB is the only penny I’m interested in at this time - sorry
More than 30 Years bio and related industry-
I believe in PMCB because I know too many dead cancer patients and diabetes sufferers. - and see this as a cure for both.
No clue
I wish
I don’t really have any- all the setbacks experienced are typical of biotech- PMCB imo has done a good job overcoming them.
I’ve actually been here since nuvilex- PMCB is the only biotech penny I’m invested in because I like the tech - I have no connection to the company.
No I just contribute when I think I have something worthwhile to say.
No lol I’m just a middle-aged biotecher.
IMO - once this platform gets approved for pc, diabetes treatment will get fda fast-tracked by the big fish who buys our tech....
Thanks but Mr Waggoner really is doing a good job- biotech has to be notoriously conservative with news - remember there are some really big fish out there whose lunch were about to eat!
Mr Waggoner is making all the smart moves here - he deserves our appreciation- imo
Yes the testing is that long, but already started and after the 2 weeks of sterility testing we will be producing the clinical material- it’s all being done in parallel- we should still be well on track for IND in March- jmo
Sterility/mycoplasma testing takes about 2 weeks... Austrianova should be receiving cells for production by end of February- imho. We’re very close now folks and super excited!