Hi there. I did call NERX concerning the ambiguity regarding the phrase "pivotal trials." For STR, it means Phase III. No ambiguity there. MGO, you are wrong about pivotal trial meaning Phase II.
I am impressed by the information flow of the new NERX. It clarifies the timeline. I like the new management's style. The interesting part of this Press Release is that they expect to start the dosimetry study in 1Q. There is only about one month left before the end of 1Q. NERX must be fairly confident about the dosimetry study to release a statement with such a definite time expectation.
So, probably 2-3 months to finish the study, and another 3 months for FDA to approve the pivotal trial brings us to September. MGO was right in thinking STR will come off the hold around October.
He is also right in thinking that there is dilution coming. To be sure, NERX will need another secondary or partnership to bring STR to approval. But, it appears NERX feels confident about funding, given their continued acceleration of burn rate.
I expect that they will want at least 50-60 million dollars(another 2 years) to feel comfortable. And, I would think 5-6 million share dilution at 10 dollars+ a share in second half of this year can definitely happen, if Pre-target data is good, and STR is off the clinical hold. This would be a good thing for the company and the shareholders.
And, that is where I believe MGO is right in his analysis, but wrong in his conclusions about what will happen to the stock price. This stock is not going to be at below 2 dollars in 6 months with the above scenario. This is going to be at above 10 by the year-end if the above scenario unfolds.
In the short term, we can expect an announcement of beginning of dosimetry study by end of March. This is an event that will probably drive the stock price to about 6 dollar range, given the previous history. And in another month and a half, we have ASCO where we'll get some data on Pre-Target. Then, we will get the completion of dosimetry study in another month or two, and then we get into expectation of FDA lifting the hold. This is not a bad timeline for an investor.
I would like to thank you Kairos for your post and for having phoned NERX for clarification. I wasn't sceptical about the details of the release, but the wording looked foggy.
After the Enron fall out, and closer to home with Imclone et al (and perhaps Nerx's reticence over STR problems in the past) I have become much more sceptical to Company Press releases and company generated financial statements. It is almost the same as writing your own CV. I have a list of 'forthcoming articles' on mine that never seem to get written, yet still they sit there. So reading the press release is like reading the resum�, but it seems that phoning for clarification of certain points and checking the facts is the interview process, whilst investing your money is giving them the job.