Member Info for PrivateRyan

extracts from last september interims

As we near our PDUFA date, we continue to evaluate additional capital raising opportunities to fund our growth and continuing operations and expect that a positive decision by the FDA will be a key driver of future value in the Company.

We will be required to raise additional capital through equity or debt financings within the next year to continue the development and commercialization of current product candidates and to continue to fund operations at the current cash expenditure levels.

also the second tranche of the hurricane loan of 5m dollars is subject to certain milestones which havent yet been met such a fda approval .So the delay in approval could be accelerating the equity raise.

Lots of evidence that the fund raise is NOT to fund more trials necessarily

Exactly dp888. Too much hysteria. Peeps should read the last interim statements. Capital raise mentioned twice I recall I hope g l appears today. He probably already had the proactive slot booked to tell us about the approval and the commercial deal! The script will need to be changed lol. Bought another 50 k this morning. In for a penny......

Is it the beginning of the end or the end of the beginning?!come on Graham we need inspiration tomorrow! This could be your finest hour. Cometh the hour...... I remain optimistic ..... Nite all contributors.

An interesting insight. Thanks

I see you too couldn’t let the infantile trek post go without comment ivy ! Fingers and toes crossed now.

An infantile view which shows no knowledge of the history and pays no attention to points made earlier eh fund raise predicted months ago by the company . Just what if ...... there were some pretty poor posts today but this is the worst They will come out fighting tomorrow I reckon

id rather take Tetch on in a heated debate-but i am retired so have the time! Sometimes he hs a point but mostly overstates his case ,and gets it wrong.eg on well flagged capital raise.

My own guess is that they were expecting to sign a big deal with upfont fee on approval so left habp etc until that funding came in! we will probably never know

For your assistance Though this is how CRLs are supposed to function, there are indicators suggesting the FDA has been using them for additional or alternative purposes. Under 21 C.F.R. § 314.100, the FDA has only 180 days in which to respond to a drug application with either an approval, rejection (very rare) or CRL. Given the complexity of NDAs and ANDAs, and the volume submitted annually to the FDA, 180 days may be insufficient for an application examiner to adequately and accurately respond. As a result, CRLs are regularly used by the FDA in order to “buy time” to review the application. This is evident in the CRLs many companies receive containing bases for holding the application deficient citing issues or guidance documents entirely irrelevant to the application in question. Because even minor changes to the application under the resubmission option in § 314.110(b)(1) will award the FDA at least an additional two months to process the application, plus the 12 months an applicant is allowed to respond to the CRL, such letters are a valuable tool in acquiring additional time to examine the NDA or ANDA and for the FDA to process other applications.

Tetch remember there were hundreds of thousands of pages in the nda. Could it be that they needed motif to pull out some data from that magnum opus? See also the poster earlier talking about c r l s being used to delay decisions due to resourcing and tight deadlines Again you overstate the case.

Don’t agree with that tetch!. It is a reminder of what was said a few months earlier. He hasn’t said as a result of the delay blah blah . You overstate your case like Brexiteers! Lol You were right on your call but were lucky. In my view We will see Wait for the. Fat lady

Petch have a look at the interims. They say there and then they will need new capital even if approval given As we near our PDUFA date, we continue to evaluate additional capital raising opportunities to fund our growth and continuing operations and expect that a positive decision by the FDA will be a key driver of future value in the Company. There is more Have a look.

Yes some gallows humour here on Valentine’s Day. I am on latrine duty now! I have sat on my hands too ...the fat lady hasn’t sung yet ....if g l indicates no new trials likely it should recover You can sense the shock and disappointment in the brief rns ...I think graham will keep calm tomorrow if that proactive video takes place

Not doubting you but any idea what time?

Glad I was of service!!

Look at motifbio.com website. Under presentation. Out today and included the fda response

Yep i had a good few quid on this one. But the fat lady hasnt sung yet!And I retain a dispassionate view on my successes and gains - take the emotion out.I can afford the loss if it happens and am mentally resigned to it.

Much was made btw about the recent 11% increase in MTFB by IIs- the masters of the universe got it wrong as well ,or at least have done so far- so dont place too much reliance on that .

I didnt- the science is good- and the evidence remains that this is a good drug- I am hopeful it is a pause rather than a full stop -apparently the company is flabbergasted at the non approval.We shall see-......they hope to meet FDA within a couple of weeks

Graham has always been quick to proactive video the good news....let’s see how he deals with this setback ...we need a feel for how serious this is

I suspect he had been writing the big rns for the approval and the deal ! This is clearly a shock to him and us. I am going to see what it all means before I jump ship. So much down now that I might as well! Hard to see if it was a serious problem it wasn’t picked up.

We can buy on nasdaq and us can buy on aim ? Expect a 700 am rns Good luck and tally ho........

Are you invested here Graham ?