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We all knew they'd be the first to go, and probably will take a short position in it once it settles down.
Congrats, you win a prize. GL has it in his man bag, get it from him next time he pops up somewhere.
eviking, until we can get the data from the CRL there is not a great deal to know, as it will be specific to the drug, and the dose given over the period, then the number of AE's during and after the dose ends.
Liver function is usually impaired the longer a treatment is administered, so it could be that there were some liver function queries based on the patients that were given the drug for a longer period of time, and it may simply be anomalies that can be explained with current data on hand. However given how thorough the FDA are (usually) they can only analyse the data they have been given, and what they have been told by the doctors at test sites when interviewed.
Let us all hope that is indeed the case, although the LTH in me says that we've hit a block and may need to run a further trial to gather the needed data.
What is interesting however, is that they maybe able to run the trial along side the HABP testing, thus killing two birds with one stone, and actually increasing the value of the drug in the longer term, even if it means short term dilution and waiting 12-18 months longer.
Greatly appreciate the sentiment, I hope you and Mrs Sheltie still have a nice Valentine's Day, obviously you'll be eating with your hands since all the sharp implements are still hidden right?
Appreciate the humor TBH, feels like I had my ring forcibly opened never mind looked at today.
Kept all of mine, no point in bailing until we hear actual news as to how bothersome this will be. If they need to do another trial and it takes another 18 months then so be it, but I'm never getting back my money unless it goes beyond 40p again.
Sheltie, Ivy, Kels, etc. You've all been along for the ride, and it was nip to the shops that turned into a trip half way around the world, and now we are possibly heading into space to go an see Saturn's rings, lets hope we don't run out of oxygen before we get there!
Many thank Ivy. I am less angry, and more upset that 3 years waiting has come to worse than a cliff edge, since the meeting in the next two months could decide the entire fate of MTFB.
Saying that, they could have the meeting and take all the data needed, then ask for a black box to be applied and then gain approval with no further delay or resubmission.
Also with regards to a resubmission if required
"(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110
The link above takes you to the guide lines for when a CRL is issued against all types of application, this includes NDA's. The guidelines seem to suggest and I quote "Request opportunity for hearing. Ask the agency to provide the applicant an opportunity for a hearing on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively."
And also "Within 60 days of the date of the request for an opportunity for a hearing, or within a different time period to which FDA and the applicant agree, the agency will either approve the application or abbreviated application under 314.105, or refuse to approve the application under 314.125 or abbreviated application under 314.127 and give the applicant written notice of an opportunity for a hearing under 314.200 and section 505(c)(1)(B) or (j)(5)(c) of the act on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively."
Oh, new corporate presentation out today, the irony.
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NzAzOTk0fENoaWxkSUQ9NDE2MTc2fFR5cGU9MQ==&t=1
Who did you speak to?
I wonder if this was why the application was delayed in the first place. I am just guessing here obviously.
I also really appreciate you going to the effort to phone and post, even if the price hasn't gone up it's made me feel a bit better.
Jimzi, I'd have to say that the cash raise would be to pay for a new trial, why else would they need funding if sitting on $10m+ already.
Do you think they tried to make it look worse than it is, or do you think they were actually blindsided by the CRL?
I'd take that right now TBH, and no doubt they'll get it approved no problem either.
Kels, same here - was sitting at a loss on my holding but this has now buried it. All we can do is hope that the information can be supplied.
Of all the COS this seemed to be the best, and we got f***ed, odds are a strange thing.
Ivy, what are the chances you'll be able to get a response from GL if you try and contact him? Obviously it is a big ask but I am f***ed if this goes the way Arpidia did, and I can't stand the thought of that.
Please when you get time, see if you can find out some further information.
I also wonder that, I'd like to think that when they say "cannot approve in its present form" they can re-form it and make it acceptable. If they can't and it needs another P3 trial, and new application that is another 2 years, and ~$40m or more maybe.
Or maybe, just maybe it cannot be fixed and the drug is no good, I'm already down 95%, as I am in at the 50-60p range for a huge sum of money so today all I can do is hope.
86DA, I was looking for that answer but it's not easy to find. Obviously the CRL was incredibly specific, and requesting more data for liver function/impact information , and having a nose around it seems that certain data could be available just not complied, at least that was in the cases I am looking at now. Some of the prices overreacted, and these are some examples where the bounce back was reasonably quick.
My question is, how long until they can present the data, and do they need to wait another 6-12 months or do they just take the new information and formally reject or accept it.
Took the letters right out of my keyboard Sheltie. It's all down to the II's if they start selling then it may be worse today than I thought.
I wonder what the time scale is to have the application re-looked at assuming they can present all of the data needed without another trial.
They've dropped it down to 40.50p now.