Rev, all of your points are relevant. Unfortunately none will be...

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Timber7

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27/04/15

18:25

Post #: 15165261
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Originally posted by Revreboot ↑

FWIW these are my thoughts about the questions and answers:
I appreciate the commitment to improve shareholder communications from this point forward - we'll see if this is borne out by action.
The question that hasn't been answered but needs to be spelled out in my opinion is whether the application before EMA goes back to day 1 now that it has been withdrawn. As I understand it currently the company will engage in further trials and will then resubmit its application to EMA. If so that would mean that the current length of delay is dictated by the planning, execution and evaluation of the trial and then a fresh submission to EMA that would then re-start the 210 day clock from the beginning. If this is the case then the delay to CE Mark from now could be in the order of 2 years. Given the company's commitment to improved shareholder communications I would ask that this be confirmed.
IMHO the company (after taking advice from SAWP) should devise trials that satisfy both EMA and FDA requirements. I would have thought it is a no brainer that costs are conserved to move forward in this way. It would appear that the EMA are after a comparative study utilising a placebo but it may also pay to put other controls into the study such as treating one cohort of patients with a placebo, one with vitronectin alone, one with IGF-1 alone and one with VG. This structure combined with double blinding and a sufficiently large sample size should cover all the requirements for both EMA and FDA. It doesn't make sense to spend money on 2 separate trials.

Rev

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Rev, all of your points are relevant. Unfortunately none will be answered in the short-term.

This is what will happen; The SAWP meeting will occur - no significant update.

A few weeks out they'll have a plan, and answers. The company has speculated that while they'll have to resubmit through EMA (obviously) it may be a shorter path to approval.

I'm waiting to buy, but not until after the CR occurs

TIS Price at posting: 10.0¢ Sentiment: Hold Disclosure: Held
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Rev, all of your points are relevant. Unfortunately none will be...

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