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Again i referred back to the European approval . and the subsequent use in actual patients .... of the TriGrid 2 device

these trials have not been stopped "despite" the FDA requesting more information as the two Authorities are not that far apart ... one can safely use the word "inevitable" indeed Scancell have actually put a time frame in for trail start H1 2019

why would they do that if they think like you ?

The issue is not Black or White ... ie. approval or not approved ...

because if that was the case Scancell being able to organise European trials would switch Tack .. and run with the European Medical agency ... expanding the UK arm of the trial ...

So the issue is you think to narrow ... rather than looking at the options of black or white

in other words Scancell last October would have shifted to Europe .. if they did not expect the inevitable approval

Its already approved in Europe ... so its a case of the Inevitable approval in the US

The manufacturer of the Gun have world wide service and don't think the word Prototype is used, as the trigrid 1 has already gone through trial ..

FDA regarding responses to those questions, and this process is completely independent as it relates to the

"FDA’s device division"

thus the 30 protocol does not apply as frustrating as that is ...

Intel was prepared to sell to third party .... IBM was a closed shop

Its like backing Intel or microsoft .... in 1980 .. who would have thought !!

now Lindy gives you Intel .. on a plate ... with all the science behind it ..

Your decision ..

well i am not on child genius

any one see that kid recall the sequence learning in one hr of 100 cards with flags of countries on and then recalling them by name in order ...

he flunked at 57 ......... FFS !! Ch4

well worth catch up ... apparently Lozan has a higher IQ lol

Actually it just shows the difficulty of finding Epitopes that are predominant on a Target cancer across the population ..
making the building of vaccines very difficult ...

which is why i keep saying, billions have been spent finding epitopes and actually how many have been found which turned out to be immunogenic ... and yet they still have to look at the Individual rather than the majority

to have universal epitopes across not only 90% of the population but across 17 cancers is astonishing ...

when will the market wake up .. the "land Grab" of autophagy in cancer patent Moditope

Unless its in RNS ... it makes no difference

I know .... but the AGM presentation had this

MODI-2 (homocitrullinated epitopes)
? New modification platform available for TCR research & development

Are you sure Ray ? that would be in RNS extending the collaboration

this BB has suffered many .... at least the left is self destructing ... williamson

my thinking ....

https://blogs.spectator.co.uk/2019/02/five-things-we-learnt-from-an-evening-with-jacob-rees-mogg/

Just lost a Vote on "labour's position on brexit" ... so the House does not want a Customs Union .. LOL

would also point out we are above the original AIM float price of the shares

Not sure if VAL can say that

easy ... they describe nothing as fantastic ....

In Fact if ONW was to issue an RNS ... it would be VAL's way ...

maybe it will become a cult

you are getting confused

we are waiting for third party information so that Scancell can issue an RNS

third parties cannot issue an RNS on scancells behalf

shareholders are not relevant they are NOT regulated ... Scancell is

how if it has not received that news .. ?

be happy ... you had no bad news today

yes but the news flow is from an outside source ......

FDA

Modi1 manufacture

CRUK scib2

BioNtech ... happy to license ?

you cannot generate an RNS ... without that third party input

what you have is one product 401 ... which has shifted position to a "palliative care product" even thou it was not trialled as a palliative care product .. and in only 7 patients So that would have to be retried against the parent drug Risperidone to prove it was not the parent drug applying clinical influence ....

You have 201 ......... in at a dose escalation stage to find Efficacy compatible with the current standard of care

what you don't have is a dosage yet that would be allowed to proceed on a bigger phase 2 trial for a period of years of treatment to prove long term efficacy against the current standard of care

you cannot keep claiming efficacy in 2 or 3 patients as significant when the time frame is 12 week dosing etc ..because you are still at the dose escalation stage

the issue is the wording of the RNS creates and illusion depending how you read it ...the transparency of clinical data would prove otherwise ... but nothing has been delivered to investors

Val 301 is still subject to the success of 201 ...

e) Resumption of clinical investigations. An investigation may only resume after FDA (usually the Division Director, or the Director's designee, with responsibility for review of the IND) has notified the sponsor that the investigation may proceed. Resumption of the affected investigation(s) will be authorized when the sponsor corrects the deficiency(ies) previously cited or otherwise satisfies the agency that the investigation(s) can proceed. FDA may notify a sponsor of its determination regarding the clinical hold by telephone or other means of rapid communication. If a sponsor of an IND that has been placed on clinical hold requests in writing that the clinical hold be removed and submits a complete response to the issue(s) identified in the clinical hold order, FDA shall respond in writing to the sponsor within 30-calendar days of receipt of the request and the complete response. FDA's response will either remove or maintain the clinical hold, and will state the reasons for such determination. Notwithstanding the 30-calendar day response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted.

Under Food and Drug Administration (FDA) regulations, an investigational new drug application (IND) is either allowed to proceed or placed on clinical hold (21 CFR 312.42). A clinical hold is an order issued by the FDA to the applicant to delay a proposed clinical investigation or to suspend an ongoing investigation.12 Jul 2018