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ANGLE is following a De Novo FDA process for the Parsortix system, as there is no predicate device. Consequently, there is inherent uncertainty over the timing of the process and its ultimate success.
We have discussed this before ,being that there is no yardstick to compare ,measure and get data from etc ,does not concern me ,in fact this Amplifies The Potential Here
so do posters think that if this further submission was not required then we could have got FDA approval now or already ?
Also is there a certain timeframe or at least anecdotal evidence that shows on norm how long after AIR does FDA Approval got ?
o/t apologies for of topic but Portage Biotech are doing some amazing stuff re Oncology ,was lucky to get in early this year prior to nasdaq listing ,larger volumes than normal ,lot in the pipeline and connections
So could Parsortix be used for a screening system ( we have discussed that our current FDA Approval is based on gleaned data and Parsortix catches CTC’s ) so it catches all cancerous CTC’ s .
So where a mamogram or similiar ie none invasive detection system is not applicable could Parsortix exactly do this ?
https://www.egtechnology.co.uk/casestudies/angle-plc-parsortix-instrument
So I have seen somewhere the costs to build and buy also test costs etc .
So how many Parsortix PR1 systems will there be in use at the moment .
How many ‘ on the shelf ‘ will they have and lastly how easily can they be made in volume ty
It’s akin to 1 share sold and a signal that news is due
Often see the reaction to large trades the next day so even though I possibly foolishly post a few large trades ( guilty of more often than not Buys ) it’s just normal day to day machinations of creating a market both for themselves and clients
So AN has on numerous occasions said that he’s hoping that AGL grow into a very large company , or more recently at this weeks Mello Event be part of one !
Yes not necessarily Counting Chickens before they are hatched however if AGL have Licensing till 2034 how will this affect them .
Will they be looking to use the Parsortix system for all other Cancers and are there any other ways that it can be used .
I know it was reported that it was used in foetal procedures so what else could they use this system for ?
Lots more big buys today